Practical Approach To PACTO

Practical Approach to
Peripheral Arterial
Chronic Total Occlusions
Subhash Banerjee
Editor
123
Practical Approach to Peripheral Arterial Chronic
Total Occlusions
Subhash Banerjee
Editor
Practical Approach to
Peripheral Arterial Chronic
Total Occlusions
Editor
Subhash Banerjee
University of Texas Southwestern Medical Center
Dallas, Texas, USA
ISBN 978-981-10-3052-9ISBN 978-981-10-3053-6(eBook)

DOI 10.1007/978-981-10-3053-6
Library of Congress Control Number: 2017936690
Springer Science+Business Media Singapore 2017

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Preface
This book is written to provide cardiovascular specialists with the tools to complete
endovascular interventions of lower extremity peripheral artery occlusions with
purpose and confidence. Effective information management and swift clinical
decision-making play a powerful role in the life of an endovascular specialist.
Acquiring chronic total occlusion (CTO) intervention skills in a systematic and
reproducible manner need not be such a grueling and arduous task. With the right
approach and comprehensive knowledge of specific tools, tackling peripheral artery
CTOs can be rewarding for both the operator and the patient. During my years as a
clinical and academic physician, training the next generation of endovascular spe-
cialists, I have watched operators initially daunted by the complexity and diversity
CTO lesions grow to master this technically challenging procedure. With its step-
by-step methodical approach, this book and its contents are designed to familiarize
the reader with the current aspects of peripheral artery CTO intervention techniques
and enable them to effortlessly bridge the gap in mastering this challenging, yet
common, medical procedure.
Dallas, TX, USA SubhashBanerjee
v
Acknowledgment and Dedication
First and foremost, I would like to thank my wife, Pooja, for her relentless support
and encouragement throughout the course of my entire career. Her strength has
allowed me to seek the knowledge and opportunities without which I would not be
the man, father, or physician I am today. For that, I dedicate this book to her.
Next, my children Avantika (Sonu) and Rahul, for never failing to make me smile
and being understanding of the many nights and mornings I have had to spend away
from home or working on this book. My parents, for allowing me to pursue my
dreams and ambitions from childhood, and my family, especially Kiki and Shivani,
for believing in and supporting me at the most primitive stages of my career.
My friend and colleague Dr. Emmanouil Brilakis (Manos), my mentor Dr. Joseph
Hill, and my coauthors for having supplied me with the knowledge, wisdom, and
opportunities that were able to make this book come to fruition. Thank you to the
community of cardiovascular specialists and to my patients who have continually
been the source of timeless inspiration throughout the course of my life.
vii
Contents
1 Medical Management ofLower Extremity Peripheral

Artery Disease 1
Akshar Y. Patel and Hitinder S. Gurm
2 Endovascular Treatment ofIliac Artery Chronic Total Occlusions 9
Kalkidan Bishu and Ehrin J. Armstrong
3 Femoropopliteal Artery Chronic Total Occlusion Intervention 23
Subhash Banerjee and Emmanouil S. Brilakis
4 Treatment ofFemoropopliteal CTO 41
Subhash Banerjee
5 Endovascular Treatment ofBelow-the-Knee Chronic
Total Occlusions 45
Anand Prasad and Fadi Saab
6 Comparative Assessment ofCrossing andReentry Devices in
Treating Chronic Total Occlusions forFemoropopliteal
andBelow-the-Knee Interventions 75
Nicolas W. Shammas
7 Complications ofPeripheral Arterial Interventions 95
Mazen Abu-Fadel
ix
Chapter 1
Medical Management ofLower Extremity
Peripheral Artery Disease
AksharY.Patel andHitinderS.Gurm
1.1 Introduction
An estimated 812 million Americans are believed to suffer from peripheral arterial
disease (PAD) according to the American Heart Association [1]. The prevalence of
PAD has been estimated at almost 10% in the general population and almost 20% in
those older than 70years. Patients with PAD present a unique challenge to the pro-
vider due to their typically older age, high rates of underdiagnosis due to asymp-
tomatic state, and the higher prevalence of comorbid conditions. The prototypical
risk factors for PAD are similar to that of coronary arterial disease and include
tobacco use, hyperlipidemia, hypertension, and diabetes. The mainstay of PAD
therapy is aggressive risk factor modification followed by pharmacologic therapy
and exercise therapy as warranted.
1.2 Risk Factor Modification
1.2.1 Tobacco Use
Though cigarette smoking is quite well known as risk factor for other cardiovas-
cular conditions, it has the absolute strongest correlation with PAD. Tobacco
use is the largest risk factor for PAD with epidemiological studies demonstrat-
ing up to a sixfold increased risk of the development of PAD in patients who
A.Y. Patel, MD H.S. Gurm, MD (*)

Department of Medicine, Samuel and Jean A.Frankel Cardiovascular Center,
University of Michigan Health System and Medical School, Ann Arbor, MI, USA
VA Ann Arbor Health Care, Ann Arbor, MI, USA
e-mail: hgurm@med.umich.edu
Springer Science+Business Media Singapore 2017 1

S. Banerjee (ed.), Practical Approach to Peripheral Arterial Chronic
TotalOcclusions, DOI10.1007/978-981-10-3053-6_1
2 A.Y. Patel and H.S. Gurm
smoke tobacco; furthermore, this risk has been demonstrated to be dose depen-
dent on the amount of tobacco use [2]. Moreover, once a patient has been diag-
nosed with PAD, the continued use of cigarettes has been directly related to the
progression of PAD and eventual limb loss. This effect is also seen in an attenu-
ation of response with the use of pharmacologic and endovascular interventions
in the PAD patient who continues to use cigarettes [3]. Studies have also dem-
onstrated an increased dose-dependent risk of PAD development in patients who
do not smoke cigarettes themselves but are a victim of secondhand smoke expo-
sure [4]. More recently, e-smoking has been increasing in popularity due to
perceived lower-risk profile; though conclusive studies on e-smokings risk on
PAD do not exist, there are some concerns that the perceived benefits of e-smok-
ing may be outweighed by greater vapor and secondhand exposure in regard to
PAD risk [5].
1.2.2 Hyperlipidemia, Hypertension, andDiabetes
Well-known lipid risk factors for PAD include elevated low-density lipoprotein
(LDL), elevated triglycerides, low high-density lipoprotein, and lipoprotein (a)
[6]. Hypertension has been demonstrated to be a risk factor for PAD development
in many long-standing population studies. In Framingham, men were two times
as likely and women four times as likely to develop PAD with intermittent clau-
dication if they were hypertensive [7]. Similarly, in the Cardiovascular Health
Study patients with a history hypertension were noted to have a 50% greater
likelihood of the development of PAD [8]. While tobacco use typically results in
PAD in the larger inflow vessels of the extremities, diabetes mellitus as a risk
factor typically results in PAD in the more distal vessels. A large meta-analysis
has demonstrated that with every one-percent increase in A1c greater than six,
there is a 30% increased risk for the incidence of PAD [9]. Moreover, diabetics
who develop PAD are known to suffer five times higher risk of amputation com-
pared to nondiabetics with PAD [10]. As such, the control of risk factors in even
those patients who have already developed PAD is an important part of the thera-
peutic plan.
1.3 T
herapeutics: Control ofRisk Factors andCV Mortality
andMorbidity
The primary goals of therapy for PAD include the prevention of myocardial infarc-
tion, stroke, and death as well as prevention of limb loss and avoidance of surgery
or endovascular procedures.
1 Medical Management ofLower Extremity Peripheral Artery Disease 3
1.3.1 Smoking Cessation Therapy
Smoking cessation is a key therapy for patients with PAD.Numerous studies have
demonstrated objective improvements in ankle pressures and walking distance as
well as reductions in need for limb amputations with tobacco cessation [11, 12]. The
treatment options for smoking cessation are varied but almost always include a
component of behavior-modification therapies including counseling and/or support
groups. Such behavior-modification therapies alone have been demonstrated as hav-
ing 20% efficacy at 1 year in eliminating tobacco use [13]. Nicotine supplementa-
tion is also often used with an efficacy of close to 50% seen at 1 year [14]. Short-term
pharmacologic options include varenicline and bupropion, both of which have been
approved by the FDA for assistance in smoking cessation; they have demonstrated
40% and 35% efficacies, respectively, at 1 year [15, 16]. The American Heart
Association and the American College of Cardiology provide a Class I (A) recom-
mendation to both advise for smoking cessation at each clinic visit as well as offer
comprehensive cessation options for all patients with PAD [17].
1.3.2 Lipid Lower Therapy withStatins
Though specific levels for PAD have not been separately stated in the guidelines, as
a CAD equivalent, similar goals of LDL <70mg/dL for high-risk patients have been
used; the utilization of statins provides a benefit with respect to reduction in myo-
cardial infarction, stroke, and vascular death rates. A Cochrane meta-analysis found
no change in ABI but did show increase in total walking distance (152 m) and pain-
free walking distance (90 m) with statin use in patients with PAD [18].
1.3.3 H
ypertension Control withAngiotensin-Converting
Enzyme Inhibition
Though the control of hypertension by any antihypertensive is beneficial in reduc-

ing the risk of PAD and vascular disease in general, angiotensin-converting enzyme
inhibitors have been shown to have a mortality benefit. The HOPE trial demon-
strated a reduction in myocardial infarction, stroke, and vascular death for patients
with PAD treated with an angiotensin-converting enzyme inhibitors; this benefit
was seen even if there was no reduction in blood pressure [19]. Furthermore, a study
comparing ramipril versus placebo demonstrated functional improvement with an
improved pain-free walking time (75s longer) and maximum walking time (255s
longer) [20].
1.3.4 Antiplatelet Therapy
Aspirin, the prototypical antiplatelet drug for vascular disease, has been shown
to provide a 23% reduction in major vascular events including myocardial
infarction, stroke, and vascular death in patients with PAD [21]. Similarly,
patients with PAD on low-dose aspirin therapy have demonstrated a 54% reduc-
tion in the risk of the morbidity of peripheral vascular surgery [22]. The CAPRIE
trial advanced antiplatelet therapy further by evaluating the P2Y12 inhibitor,
clopidogrel, against aspirin therapy in PAD patients; it demonstrated a 24%
reduction in the risk of myocardial infarction, stroke, and vascular death [23].
The CHARISMA trial attempted to demonstrate a benefit in dual-antiplatelet
therapy (aspirin and clopidogrel) over aspirin-only therapy. However, though
secondary analyses did demonstrate a major cardiovascular outcomes benefit
for dual-antiplatelet therapy in a composite of patients with prior myocardial
infarction, prior stroke, and prior PAD, it failed to demonstrate a statistically
significant difference in those patients with only prior PAD [24]. As such, the
current American College of Cardiology and American Heart Association
guidelines provide for a Class I recommendation of clopidogrel alone with a
Class IIb recommendation for clopidogrel and aspirin dual-antiplatelet therapy
as a reasonable more intensive therapeutic option in those patients who warrant
it [17].
1.4 Therapeutics: Improvement ofFunctional Capacity
The secondary goal of PAD therapy is to improve functional capacity and symptoms
including pain-free activities, walking ability, and the delaying of limb amputation
(Fig. 1.1).
1.4.1 Supervised Exercise Therapy (SET)
Arguably the most important intervention in terms of overall benefit for the patient
may be supervised exercise therapy. It has been found to promote angiogenesis [25],
improve endothelial function [26], and increase muscle strength [27]. A meta-
analysis has demonstrated an improvement of 50200% in walking ability (4.5min
increase in mean maximal walking time, increase in pain-free walking of 82 m,
increase in maximal walking distance of 109m at 2years) [18]. Supervised exercise
therapy is defined as including the following: at least three times per week, at least
30min per session, and at least 12weeks in total duration and interval training with
moderate claudication at rest point.
Myocardial infarction Functional capacity No benefit
Therapy Risk reduction Mortality benefit Limb morbidity benefit
and stroke reduction improvement or harm
Smoking cessation
Statin
ACE-Inhibitor
Antiplatelet
Supervised exercise
Cilostazol
Pentoxifylline x
Naftidrofuryl
Propionyl-L-carnitine
L-arginine x
ginkgo biloba extract x

1 Medical Management ofLower Extremity Peripheral Artery Disease
Fig. 1.1 Peripheral arterial disease therapeutics

5
1.4.2 Cilostazol
Cilostazol is a unique drug in that it inhibits phosphodiesterase 3 leading to an

increase in cyclic adenosine monophosphate and subsequent arterial smooth muscle
dilation via increased levels of nitrogen oxide. Though cilostazol has failed to dem-
onstrate a mortality benefit, it has been found to be useful in improving functional
capacity; it has been shown to result in a twofold improvement in maximal walking
distance (absolute improvement of 42 m). Additionally, for the patients undergoing
endovascular interventions, cilostazol has been shown to be useful in reducing res-
tonsis [28, 29].
1.5 T
herapeutics: Investigational, Failed, andOther
Therapies
Various therapeutics have been trialed in the treatment of PAD to no avail.

Pentoxifylline is a medication with numerous proposed mechanisms of action
including inhibition of platelet aggregation and lowering of plasma fibrinogen
levels. Though it has been in use for many years, there is no evidence that it is
any more effective than placebo [30]. Naftidrofuryl is a medication which pur-
portedly acts as a vasodilator as well as an enhancer of cellular oxidative capac-
ity. Though not available in the United States of America, it has been approved
for use in the European Union since 1972. Meta-analyses have both demon-
strated a similar benefit as cilostazol with naftidrofuryl in regard to functional
capacity improvement when compared to pentoxifylline [31]. Propionyl-L-
carnitine is a key amino acid involved in the pathway of free fatty acid and
glucose oxidation, both of which are altered in patients with PAD. In animal
models a reduction in oxidative stress has been seen with carnitine supplemen-
tation [32]. In a meta-analysis of human subjects, carnitine therapy, a trend
toward functional benefit with improvements in maximum walking, was seen
with the greatest benefit in those patients with severe claudication [33].
L-Arginine is another amino acid that has been hypothesized to be of benefit as
it is a precursor to nitric oxide a potent vasodilator. In the NO-PAIN study, 3 g
of daily oral supplementation with L-arginine over a 6-month period in patients
with PAD resulted in a statistically significant lower improvement in functional
capacity as compared to placebo [34]. As such L-arginine is felt to be of no
benefit and may even be harmful to patients when taken chronically. Similarly,
Ginkgo biloba extract, a vasoactive agent, has been studied in numerous small
trials for patients with PAD.A recent Cochrane meta-analysis demonstrated no
clinically significant benefit of Ginkgo biloba extract supplementation in
patients with PAD [35].
1 Medical Management ofLower Extremity Peripheral Artery Disease 7
1.6 Conclusion
Peripheral arterial disease is a common and often underdiagnosed and undertreated

vascular condition. Control of risk factors, especially smoking cessation, is the main-
stay of therapy for the reduction of cardiovascular morbidity and mortality. The addition
of antiplatelet therapies as well as supervised exercise therapy among other therapeutics
is often of benefit as well for functional improvement in walking capacity.
References
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27. Hiatt WR et al. Effect of exercise training on skeletal muscle histology and metabolism in
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29. Dawson DL etal. Cilostazol has beneficial effects in treatment of intermittent claudication:
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33. Delaney CL etal. A systematic review to evaluate the effectiveness of carnitine supplementa-
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Chapter 2
Endovascular Treatment ofIliac Artery
KalkidanBishu andEhrinJ.Armstrong
2.1 Introduction
Approximately 8.5 million American adults are affected by peripheral artery dis-
ease (PAD). The iliac arteries and infrarenal aorta are among the arterial circulations
most commonly affected by atherosclerotic chronic total occlusion (CTO) and con-
stitute approximately one third of cases of PAD.Percutaneous angioplasty for iliac
CTO was first described by Tegtmeyer et al. in 1979 in a 55-year-old diabetic
woman with nonhealing foot ulcers in association with a CTO of the right common
iliac artery (CIA) [1]. While surgical bypass can be performed with high long-term
patency for aortoiliac PAD, endovascular interventions are increasingly being used
to treat disabling claudication in such patients [2]. Surgical bypass options vary
based on the specific anatomy, but include aortofemoral or aorta bi-femoral bypass,
iliofemoral bypass, femoral-femoral bypass, and aortoiliac endarterectomy. Surgical
bypass is associated with satisfactory improvement in symptoms and long-term
patency rates, but such operations may incur significant operative morbidity and
mortality. Thus endovascular aortoiliac interventions are often considered as a first-
line treatment strategy for symptomatic patients with aortoiliac disease [2, 3].
The Trans-Atlantic Inter-Society Consensus (TASC) II document provides a
classification of aortoiliac lesions according to the level of complexity (types A, B,
C, and D) that can be used to guide the revascularization approach (Fig. 2.1) [4].
Conflict of Interest (or Disclosures) EJA is a consultant for Abbott Vascular, Medtronic, Merck,
Pfizer, and Spectranetics.
K. Bishu, MD, MS E.J. Armstrong, MD, MSc, MAS (*)

Division of Cardiology, University of Colorado, Aurora, CO, USA
Denver VA Medical Center, 1055 Clermont Street, Denver, CO 80220, USA
e-mail: Ehrin.armstrong@gmail.com

10 K. Bishu and E.J. Armstrong
Type A lesions
Unilateral or bilateral stenoses of CIA
Unilateral or bilateral single short (<3 cm) stenosis of EIA
Type B lesions
Short (<3cm) stenosis of infrarenal aorta
Unilateral CIA occlusion
Single or multiple stenosis totaling 310 cm involving the
EIA not extending into the CFA
Unilateral EIA occlusion not involving the origins of
internal iliac or CFA
Type C lesions
Bilateral CIA occlusions
Bilateral EIA stenosis 310 cm long not extending into
the CFA
Unilateral EIA stenosis extending into the CFA
Unilateral EIA occlusion that involves the origins of
internal iliac and/or CFA
Heavily calcified unilateral EIA occlusion with or without
involvement of origins of internal iliac and/or CFA
Type D lesions
Infra-renal aortoiliac occlusion
Diffuse disease involving the aorta and both iliac arteries
requiring treatment
Diffuse multiple stenoses involving the unilateral CIA,
EIA, and CFA
Unilateral occlusions of both CIA and EIA
Bilateral occlusions of EIA
lliac stenoses in patients with AAA requiring treatment
and not amenable to endograft placement or other
lesions requiring open aortic or iliac surgery
Fig. 2.1 TASC II classification of aortoiliac peripheral arterial disease. CIA common iliac artery,
EIA external iliac artery, CFA common femoral artery, AAA abdominal aortic aneurysm
(Reproduced with permission from Norgren etal. [4])
Type A lesions are the least complex focal stenoses of the CIA or the external iliac
artery (EIA). Type B lesions are unilateral CIA or EIA occlusions (not involving the
common femoral artery (CFA) or internal iliac artery (IIA) origins). Type C lesions
are bilateral CIA occlusions, unilateral EIA occlusions that are heavily calcified or
involve the CFA or IIA origins. Type D occlusions include aortoiliac occlusion,
unilateral occlusions of the CIA and EIA, and bilateral EIA occlusions. While the
TASC documents recommended endovascular treatment for type B occlusions and
surgical bypass for type C and type D lesions, with increasing operator experience,
type C and D lesions are increasingly being treated via an endovascular approach
[5]. In addition, procedural success rate does not appear to be a function of the
TASC II classification (which is primarily defined by anatomic involvement) and
may instead be related to underlying characteristics of the occluded segment (e.g.,

calcification, ease of reentry, etc.).
2.2 Outcomes After Endovascular Treatment ofIliac CTOs
Endovascular recanalization assisted with stenting is increasingly being performed in

the treatment of iliac CTOs with satisfactory long-term patency rates. Stenting is the
primary strategy in the endovascular treatment of iliac occlusions and is associated with
high long-term patency rates compared to angioplasty alone [6]. In a meta-analysis of
1300 patients with iliac disease treated with angioplasty or angioplasty with stenting,
among patients with stenosis as well as occlusions, patency rates at 4years were supe-
rior for stenting compared to angioplasty alone (61% vs. 54% for chronic limb isch-
emia patients with iliac CTOs and 53% vs. 44% for claudicants with iliac CTOs) [6].
Most other data regarding long-term outcomes of iliac CTOs treated with stent-
ing are limited to observational studies of one or two centers. Scheinert etal. treated
212 patients with unilateral iliac CTOs via an endovascular approach with excimer
laser-assisted recanalization and stent implantation [7]. The authors reported an
84% primary patency rate at 1year. Contralateral crossover antegrade crossing of
the lesion was accomplished in 91%, whereas in the remaining 9% an ipsilateral
retrograde approach was used. Similarly, Carnevale etal. treated 69 iliac CTOs with
a 97% technical success rate [8]. The primary patency at 1 year was 91%. Leville
etal. treated 89 patients with iliac CTOs with a 91% procedural success rate. Three-
year primary patency was 76%. The prevalence of TASC B, C, and D lesions was
25%, 34%, and 42%, respectively. Technical success rates were similar at 95%,
94%, and 86% in the different TASC groups, respectively [9].
In a larger observational study, Ozkan etal. treated 127 limbs in 118 patients
with iliac CTOs. Lesions were in the common iliac artery, external iliac artery, and
combined common and external iliac arteries in 53%, 28%, and 19% of patients,
respectively [10]. Seven percent of patients had bilateral common iliac artery (CIA)
occlusions, most of whom had total aortoiliac occlusions. Recanalization was
attempted from the ipsilateral retrograde approach first, which was successful in
50% of cases. In the case of failed ipsilateral approach, a contralateral crossover
antegrade approach was attempted which was subsequently successful in 90% of
cases. Primary patency at 5years was 63%.
Multiple other studies have suggested that the TASC II classification of iliac
CTOs may not be associated with procedural success or long-term patency. Chen
et al. treated 120 patients with iliac CTOs with successful recanalization in 101
CTOs. 39%, 27%, and 35% of lesions were TASC II types B, C, and D, respectively.
A reentry device (Pioneer or Outback) was required in 14% of lesions that were
successfully revascularized. The primary patency at 1year was 86% [10]. Dattilo
etal. performed 63 iliac CTO endovascular interventions with a procedural success
rate of 97%. 59%, 7%, and 37% of lesions were TASC II types B, C, and D, respec-
tively [5]. Technical success rates were not different in the different TASC II sub-
types. Papakostas et al. treated iliac CTOs in 56 limbs in 48 patients by the

endovascular approach with stent implantation with a 91% procedural success rate.
30%, 32%, and 38% of lesions were TASC II types B, C, and D, respectively.
Primary patency (peak systolic velocity of <2.5% on arterial duplex US) at 3 years
was 91%. TASC II type was not associated with procedural success or patency [11].
In summary, current observational studies have demonstrated that iliac artery
CTOs can be treated via endovascular techniques with success rates exceeding 90%
in most cases. The long-term patency of iliac artery CTOs is also high after success-
ful endovascular treatment, suggesting that endovascular treatment of iliac artery
CTOs is a reasonable first-line treatment strategy for most symptomatic iliac artery
CTOs.
2.3 Treatment Strategies andIllustrative Cases
The approach to iliac CTO endovascular recanalization primarily depends on the

anatomic location of the occlusion. This section provides a general overview for
treatment of iliac artery CTOs, followed by illustrative cases that demonstrate the
technical approach to treatment of specific anatomic subgroups.
2.3.1 Overall Approach andTreatment Strategy
Endovascular treatment of iliac artery CTOs should be based on detailed pre-

procedure planning in order to determine the optimal treatment approach and
maximize the chances of technical success. In cases where an iliac artery CTO is
suspected, pre-procedural CTA imaging can be invaluable in providing specific
anatomic detail including the presence and amount of vessel calcification, the
location of occlusion and site of reconstitution, and the location of collateral
vessels.
Multiple sites of arterial access may be necessary for successful treatment of
iliac artery CTOs. Whenever possible, a 7 French sheath should be employed; the
larger sheath size makes it possible to deliver covered stents and/or a larger occlu-
sion balloon in the case of iliac artery perforation. The most frequent access involves
bilateral common femoral artery access, in order to provide adequate vessel imag-
ing from above and multiple treatment options, including combined antegrade/ret-
rograde crossing in case of challenging lesion crossing. Brachial access may provide
additional backup support for challenging lesions, especially ostial or proximal
occlusions of the common iliac artery. In such cases, left brachial access should be
obtained, and a 90cm shuttle sheath used to maximize backup support [12]. Radial
access may also be useful for aortoiliac imaging or for treatment of proximal com-
mon iliac artery disease [13]. However, the shaft length of most endovascular
devices makes treatment of more distal external iliac lesions difficult from a radial
approach. Rarely, popliteal or pedal access may be necessary for successful treat-
ment of an iliac artery CTO, but should be reserved for cases where there is con-
comitant common femoral artery disease that may need to be treated from a
retrograde approach in order to preserve the bifurcation of the profunda femoris
with the superficial femoral artery.
The optimal approach for crossing an iliac artery CTO remains uncertain.
Retrograde crossing from ipsilateral common femoral artery access has the advan-
tage of treating from the same side, thereby avoiding the need for a crossover sheath.
However, imaging from a retrograde sheath is often suboptimal, and contralateral
access may be required regardless to image the proximal lesion cap. Antegrade
access may have a higher success rate for crossing of the occlusion, but subsequent
treatment usually requires wire externalization, which increases the overall com-
plexity of the procedure. If one wire crossing strategy is not successful, it is reason-
able to switch strategies and attempt a true lumen crossing from the other direction
prior to using dedicated reentry techniques. In some cases, wire advancement may
be necessary from both directions simultaneously, followed by a CART or
reverse CART technique to reconcile the subintimal space and cross the cap into
the true lumen [14].
No specific data exists on the optimal stent type for treatment of iliac CTOs.
Most operators choose a strategy of balloon expandable stents for treatment of com-
mon iliac artery disease due to the more predictable deployment of such stents, and
a self-expanding stent for treatment of external iliac artery disease, due to the
increased conformability of these stents in the tortuous external iliac artery. The
COBEST trial did demonstrate superior patency of covered balloon expandable
stents in the treatment of TASC C and TASC D lesions, suggesting that this stent
type may have some relative benefit in the treatment of complex iliac artery CTOs
[15].
2.3.2 Ostial Common Iliac or Aortic Bifurcation
Treatment of ostial CIA occlusion or aortic bifurcation disease involving the bilat-
eral common iliac ostia can most often be accomplished using bilateral retrograde
common femoral artery (CFA) access and kissing angioplasty/stenting. Crossing
the lesion may be attempted from the retrograde approach initially. Such an approach
is associated with 50% success rate [10]. If this approach fails, contralateral cross-
over antegrade approach is usually successful in crossing the lesion, with a reported
90% success rate based on limited data. Ultrasound guidance or roadmaps are help-
ful in accessing the patency of the CFA distal to a CIA occlusion, which can deter-
mine the use of a short brite tip sheath for distal access. A 7F sheath is required
usually due to the caliber of stents required to treat CIA disease, especially if bal-
loon expandable covered stents are used. The stents should be extended approxi-
mately 5mm into the distal abdominal aorta, but the extent of coverage depends on
the presence of distal abdominal aorta disease and the angulation of the bifurcation.
a b c d
Fig. 2.2 Digital subtraction aortoiliac angiography showing right CIA occlusion involving the
ostium (a). Lesion crossed using a 0.035 straight stiff Glidewire supported by a Simmons 1 cath-
eter (b). The wire was exteriorized through the right CFA sheath (c). Atrium iCAST stents deployed
in kissing stent fashion at bilateral iliac artery origins into the distal abdominal aorta (d)
Such an approach will usually prohibit contralateral crossover during subsequent

procedures, especially if the stents are extended into the distal aorta. When the com-
mon iliac branches are larger in caliber and the distal abdominal aorta may not
accommodate the two stents protruding into its lumen, a self-expanding stent may
be used. In rare cases, self-expanding covered iliac stent grafts (which are typically
used for endovascular aortic repair) may be necessary to accommodate ectatic iliac
arteries.
Illustrative cases using an endovascular approach to treat ostial CIA disease are
described below:
Case 1. A 65-year-old male with Rutherford Class III right lower extremity clau-
dication and an ostial right CIA occlusion (Fig. 2.2a) was brought to the cardiac
catheterization laboratory. 7F bilateral CFA access was obtained using ultrasound
guidance and a micropuncture technique. An initial attempt at crossing the occlu-
sion from the right ipsilateral retrograde direction with a 0.035 straight stiff
Glidewire was unsuccessful. A contralateral antegrade approach was successful in
crossing the lesion using a 0.035 straight stiff Glidewire supported by a Simmons
1 catheter (Fig. 2.2a). The wire was exteriorized through the right CFA sheath (Fig.
2.2c) followed by angioplasty and placement of balloon expandable covered stents
in kissing stent fashion at the bilateral common iliac artery origins into the distal
abdominal aorta (Fig. 2.2d).
Case 2. A 68-year-old male presented with Rutherford Class III bilateral lower
extremity claudication. There was a CTO of the left CIA including the ostium and
severe proximal stenosis of the right CIA (Fig. 2.3a). 7F bilateral CFA access was
obtained using ultrasound guidance and a micropuncture technique. The left CIA
occlusion was crossed using a 0.035 straight stiff Glidewire from the ipsilateral
retrograde approach supported by a Navicross catheter (Fig. 2.3b, c). Kissing bal-
loon angioplasty was performed followed by kissing stents placed in the bilateral
common iliac arteries proximally extending into the distal abdominal aorta using
balloon expandable covered stents (Fig. 2.3d).
a b c d
Fig. 2.3 Digital subtraction aortoiliac angiography showing left CIA occlusion involving the
ostium (a). The left CIA occlusion was crossed using a 0.035 straight stiff Glidewire from the
ipsilateral retrograde approach supported by a Navicross catheter (b, c). Kissing stents were placed
in bilateral common iliac arteries proximally extending into the distal abdominal aorta using
Atrium iCAST balloon covered expandable stents (d)
The strategy of using aortoiliac kissing stents has been shown to maintain long-
term patency in multiple studies. Mendelsohn etal. treated 20 patients with kissing
iliac stents for aortoiliac artery disease involving both (n=15) common iliac artery
origins and complex unilateral iliac artery ostial disease [16]. Scheinert etal. treated
48 patients with aortoiliac bifurcation disease (including 22 with unilateral occlu-
sion and contralateral stenosis and one patient with bilateral iliac occlusion) with
excimer laser-assisted recanalization and kissing stent placement [17]. The primary
angiographic patency at 2 years was 87%. Yilmaz et al. treated 68 patients with
aortoiliac disease (including 26 patients with unilateral CIA occlusion and contra-
lateral stenosis) with kissing stents [18]. The primary patency at 1 year was 76%.
Self-expanding stents were used in 76%, and balloon expandable stents were used
in 24% of patients. Mohamed etal. treated 24 patients with aortoiliac disease with
kissing stents and reported a 1-year primary rate of 81% [19]. Predominantly self-
expanding stents were used. Bjorses etal. reviewed the use of kissing stents in 173
patients with aortoiliac occlusive disease and reported a 1-year primary patency rate
of 97% [20]. Fifty-one percent of patients received self-expanding stents, 30%
received balloon expandable stents, 13% received a combination of self-expanding
and balloon expandable stents, whereas 6% of patients received covered stents.
Haulon et al. reported the results of 106 patients treated with aortoiliac kissing
stents with a primary 1-year patency rate of 79% [21]. Self-expanding stents were
used in 59% of cases, whereas balloon expandable stents were used in 41% of cases.
Some limited data also suggests that covered balloon expandable stents may be
superior to bare metal balloon expandable stents at the aortic bifurcation. Sabri etal.
treated 26 patients with aortoiliac disease with covered balloon expandable stents
and 28 patients with bare metal balloon expandable stents in a kissing stent fashion
and noted superior long-term patency with the covered stents (92% vs. 78% 1-year
patency rate) [22].
a b c d
Fig. 2.4 Digital subtraction aortoiliac angiography showing left CIA occlusion involving the
ostium (a). Contralateral right CFA sheath was exchanged for a Morph AccessPro steerable sheath
which was advanced to the distal abdominal aorta and used to provide support for crossing the left
CIA lesion with a straight stiff 0.035 Glidewire from the contralateral crossover retrograde
approach (b). A Quick-Cross Capture catheter was advanced in the left CFA sheath and advanced
to the left EIA where the wire used to cross the occlusion from the retrograde approach was cap-
tured and exteriorized into the ipsilateral sheath (c). iCAST covered balloon expandable stents
were delivered from the ipsilateral approach into bilateral proximal common iliac arteries and
deployed (d)
Case 3. A 68-year-old male with severe left lower extremity claudication was
found to have a left proximal common iliac CTO involving the ostium (Fig. 2.4a).
7F bilateral CFA access was obtained. After an initial unsuccessful attempt at cross-
ing the lesion from the ipsilateral retrograde approach, the contralateral right CFA
sheath was exchanged for a Morph AccessPro steerable sheath, which was advanced
to the distal abdominal aorta and used to provide support for crossing the left CIA
lesion with a straight stiff 0.035 Glidewire from the contralateral crossover
retrograde approach (Fig. 2.4b). A Quick-Cross Capture catheter was advanced in
the left CFA sheath and advanced to the left external iliac artery (EIA) where the
wire that had been used to cross the occlusion from the retrograde approach was
captured and exteriorized into the ipsilateral sheath (Fig. 2.4c). iCAST covered bal-
loon expandable stents were delivered from the ipsilateral approach into bilateral
proximal common iliac arteries and deployed (Fig. 2.4d).
2.3.3 N
on-ostial Common Iliac Artery andProximal External
Iliac Artery CTOs
Non-ostial common iliac artery and proximal external iliac artery CTOs can be
treated from an ipsilateral CFA retrograde or a contralateral antegrade approach.
Common iliac artery CTOs with a proximal stump can also be treated from either
the retrograde or the antegrade approach using crossover contralateral access or
brachial access.
a b c d
Fig. 2.5 Digital subtraction angiography with landmarking demonstrated a CTO of the right
external iliac artery (a). The occlusion is in the proximal external iliac artery, and there is also
significant stenosis at the origin of the internal iliac artery. A crossover sheath was advanced to the
right common iliac artery, and a straight stiff 0.035 Glidewire was used to cross the occlusion.
Due to significant stenosis at the ostium of the internal iliac artery, a wire was also passed into this
vessel, and balloon angioplasty was performed (b). A self-expanding stent was placed in the right
external iliac artery (c). Final angiography revealed patency of the right internal iliac artery and
external iliac artery (d)
Case 4. A 54-year-old man with a history of Rutherford III right lower extremity
claudication underwent lower extremity angiography, which revealed an occluded
right external iliac artery just distal to the origin of the right internal iliac artery (Fig.
2.5a). The lesion was approached from a contralateral antegrade approach, and the
occlusion was successfully crossed using a straight stiff 0.035 Glidewire into the
true lumen of the distal external iliac artery. Because of the high-grade disease at the
origin of the right internal iliac artery, a 0.014 wire was advanced into the internal
iliac artery, and balloon angioplasty was performed at the ostium of the internal iliac
artery (Fig. 2.5b). A self-expanding stent was then placed along the length of the
right external iliac artery (Fig. 2.5c), with excellent angiographic result (Fig. 2.5d).
2.3.4 Distal External Iliac Artery CTOs
Distal external iliac artery lesions are ideally treated using a contralateral crossover
approach, due to the potential difficulty in gaining arterial access in the ipsilateral
common femoral artery and attendant lack of sheath support. Balloon expandable
stents may be used if in close proximity to the hip joint due to the concern regarding
failure of self-expanding stents in this location. A contralateral crossover sheath can
be placed with its tip in the CIA and used to cross the occlusion and perform angio-
plasty and stenting from the antegrade approach.
An illustrative case of the endovascular treatment of an external iliac CTO is
described below.
Case 5. A 72-year-old male with Rutherford Class III right lower extremity clau-
dication and a history of prior left EIA stenting was brought to the catheterization
laboratory. There was a chronic occlusion of the length of the external iliac artery
(Fig. 2.6a). A 6F Morph AccessPro steerable sheath was advanced in the left CFA
and directed into the right CIA.A 0.035 support wire was advanced into the right
internal iliac artery for advancement of a crossover sheath into the right CIA (Fig.
2.6b). A 0.035 stiff Glidewire was directed into the EIA on the right but remained
in the subintimal space. Right dorsalis pedis access was obtained, and a Prowater
0.14 wire was advanced retrograde into the right EIA but remained in the s ubintimal
a b c
d e
Fig. 2.6 Digital subtraction angiography showing CTO of the right external iliac artery (a).
Following placement of a 6F Morph AccessPro steerable sheath was in the left CFA and directed
into the right CIA, and 0.035 support wire was advanced to the right internal iliac artery for
advancement of a crossover sheath into the right CIA (b). Reverse-controlled antegrade and retro-
grade subintimal tracking (CART) technique. A 0.035 wire in the subintimal space from the
crossover antegrade approach with a Charger balloon and a 0.014 guide wire placed retrograde in
the subintimal space from the ipsilateral DP (c). The retrograde advanced Probate wire used to
reenter the luminal space and externalized through the cross over sheath in the left CFA (d). An 8
80 Absolute Pro self-expanding stent advanced antegrade from the contralateral approach and
deployed along the length of the EIA on the right (e)
space. A 6.0 40mm Charger balloon was advanced over the 0.035 wire that was
advanced antegrade in the subintimal space in the right EIA and inflated in the sub-
intimal space to create a communication with the separate subintimal space created
by the retrograde wire within the occlusion of the right EIA.The retrograde Prowater
wire was used to reenter the luminal space and directed into the right EIA and CIA
and was externalized through the sheath in the left CFA (Fig. 2.6d). The wire was
exchanged for a 0.035 guide wire over which angioplasty was performed from the
retrograde approach. An 8 80mm Absolute Pro self-expanding stent was advanced
from the contralateral approach and deployed along the length of the EIA on the
right (Fig. 2.6e).
The successful use of the controlled antegrade and retrograde subintimal track-
ing (CART) technique, initially described to facilitate recanalization of coronary
CTOs, has been successfully used in the treatment of EIA occlusion in the past [14].
In this case we describe the use of reverse CART technique in which the occlusion
is crossed from a retrograde wire in the subintimal space. Intravascular ultrasound-
guided true lumen reentry devices have also been used for recanalization of iliac
artery occlusion [23]. A 100% technical success rate was reported in a series of 11
patients (seven, one, and three patients had unilateral CIA, EIA, and combined CIA/
EIA occlusions). The Pioneer reentry catheter was used in that study, although the
Outback catheter can also be used for successful reentry of iliac artery CTOs [10].
2.4 Conclusions
Iliac artery chronic occlusions are a source of increased morbidity among patients
with PAD.While surgical bypass has a high long-term patency, it is associated with
significant morbidity. Recent advances in techniques and equipment used for endo-
vascular recanalization have made the endovascular approach a plausible option for
the initial treatment of patients with iliac CTOs, with a procedural success rate
exceeding 90%. Future research should better define the optimal initial crossing
strategy in order to maximize the chances of expedient occlusion crossing.
Additional data regarding the outcomes of different stent types will also be helpful
in defining the optimal endovascular treatment of iliac artery CTOs.
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JP. Percutaneous reconstruction of the aortoiliac bifurcation with the kissing stents tech-
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Chapter 3
Femoropopliteal Artery Chronic Total
Occlusion Intervention
SubhashBanerjee andEmmanouilS.Brilakis
Femoropopliteal (FP) artery endovascular intervention procedures are one of the most
common lower extremity peripheral artery interventions (PAI) worldwide. Chronic
total occlusions are highly prevalent in this vascular bed and comprise nearly 4050%
of lesions treated [1]. Intervention on FP CTO lesions is technically more challenging,
is an independent predictor of procedure failure, and is associated with higher compli-
cation rates compared with non-FP CTO procedures [2]. Therefore, a systematic and
step-by-step approach to such lesions, along with familiarity with various PAI tools
and their attributes, is crucial to successful PAI interventional practice. In this chapter
we will review a step-by-step approach to FP CTO.Given the high likelihood of tack-
ling such lesions in clinical practice, the ability to treat FP CTO is nearly obligatory
for an endovascular specialist treating patients with peripheral artery disease (PAD).
The following topics are covered in this section:
1 . Imaging FP CTO
2. Key definitions
3. Procedure planning
4. Vascular and lesion access
5. FP CTO crossing strategies
6. Treatment options for FP CTO lesions
Imaging FP CTO The diagnosis of FP CTO lesion in patients referred for clinically
indicated endovascular treatment of PAD includes: duplex ultrasound (DUS), computed
S. Banerjee, MD (*)
University of Texas Southwestern Medical Center and Veterans Affairs North Texas Health
Care System, Dallas, TX, USA
e-mail: subhash.banerjee@utsouthwestern.edu
E.S. Brilakis
Minneapolis Heart institute, Minneapolis, MN, USA
University of Texas Southwestern Medical Center, Dallas, TX, USA
e-mail: esbrilakis@gmail.com
24 S. Banerjee and E.S. Brilakis
tomography angiography (CTA), magnetic resonance angiography (MRA), and invasive

contrast angiography (CA). CA is the most commonly used modality for diagnosis and
procedure planning of FP CTO interventions. It allows optimal visualization of lower
extremity (LE) peripheral artery anatomy, FP CTO lesion location, determination of
lesion length, distal reconstitution (distal target), below-the-knee filling, vascularization
of the feet, calcification, nature of the CTO stumps, collateral filling, and anatomy and
tortuosity of contralateral iliac, profunda femoris, and pedal vessels. This information is
crucial for planning a treatment strategy and vascular access. None of the other imaging
modalities provide as complete and accurate information for planning FP CTO interven-
tion as CA.However, the technique and quality of CA imaging is an important element
and requires careful and deliberate attention. Imaging of inflow iliac and common femo-
ral arteries is important, digital subtraction angiography (DAS) is preferred, and it is
advisable to begin imaging sequence with an abdominal aortogram with the imaging
frame set to capture at least 1020mm of the infrarenal aorta superior to the aortic bifur-
cation and both common femoral arteries. This would allow the operator to not only
appreciate any aortoiliac disease and the steepness of the aortoiliac artery bifurcation,
but also any accessory renal artery takeoffs from the common iliac arteries. Assessment
of vascular calcification, tortuosity of the external iliacs, presence of prior iliac artery
stents, and state of the profunda femoris origin provide tremendously important informa-
tion for case planning. A marker pigtail catheter or a RIM catheter (AngioDynamics,
Latham, NY) placed 1020mm above the aortoiliac bifurcation is optimal for this pur-
pose, along with appropriate instructions to the patient and even a practice breath hold-
ing run to optimize DSA abdominal aortographic image capture (Fig. 3.1).
Following aortography, dropping the RIM catheter to engage the contralateral com-
mon iliac artery origin is the next best step. From here, there are two imaging options.
One could inject into the common iliac artery and image the contralateral common
femoral artery (CFA) bifurcation, panning down to capture mid and distal superficial
femoral artery (SFA) angiograms, or rely on the image of the CFA bifurcation acquired
during aortography and plan selective injection into of the CFA.The latter can be per-
formed by advancing a supportive hydrophilic 0.035-inch guidewire (Glidewire
Abdominal aorta
Lumbar artery
Common iliac arteries

Inferior mesenteric artery
External iliac arteries Internal iliac arteries
Right common
femoral artery
Fig. 3.1 Abdominal aortogram

Advantage; Somerset, NJ) through the RIM catheter into the distal SFA, or as far as
possible, and advancing a straight tip end-hole 0.035-inch catheter (CXI; Bloomington,
IN) into the SFA after withdrawing and exchanging out the RIM.Advancing the RIM
catheter into the distal SFA is possible; however injecting contrast through its curved
tip positioned against the vessel wall may result in SFA dissection and contrast stain-
ing. However, careful manipulation of the RIM and monitoring of arterial pressure
tracing from its tip can be safely performed. Selective cannulation of the SFA allows
FP and below-the-knee artery (BTK) angiography. Such angiography under DSA can
often be performed with limited contrast (often 1:11:3 contrast to saline dilution) and
provides high-quality angiograms of distal vessels. If abdominal aortography demon-
strates occlusion of ostial or proximal SFA, selective angiography of the CFA with
BTK and distal SFA imaging under DSA is the only alternative and helps determine
distal FP reconstitution and/or BTK and distal foot perfusion. In patients with critical
limb ischemia (CLI), delineation of pedal vessels is necessary. In claudicants, at least
imaging up to the ankle vessels is highly recommended. It is best to set yourself up to
image pedal vessels in all cases, and therefore selective DSA distal FP or BTK angi-
ography is preferable to runoffs in the absence of proximal SFA occlusion.
CFA bifurcation anatomy is invariably symmetrical bilaterally, and often the ori-
gin of a SFA with flush ostial occlusion (no nub) can be estimated based on its con-
tralateral takeoff or careful examination of the CFA bifurcation angiogram for linear
calcification tracks that often follow an occluded SFA course. A medial origin of the
profunda femoris to the SFA or a high bifurcation of CFA needs to be considered and
can be infrequently encountered in clinical practice (Fig. 3.2). The inferior epigastric
a b
4
3
1
a and b: Illustrate medial origin of the profunda femoris artery (1) from the common femoral artery
(2). The profunda femoris lies medial to the superficial femoral artery (3) and the inferior
epigastric artery originated from the proximal profunda femoris artery (4).
Fig. 3.2 Anomalous origin of the profunda femoris artery. (a, b) Illustrate medial origin of the
profunda femoris artery (1) from the common femoral artery (2). The profunda femoris lies medial
to the superficial femoral artery (3) and the inferior epigastric artery originated from the proximal
profunda femoris artery (4)
artery origin is an excellent guide to the intrapelvic boundary of the external iliac
artery and is important to identify both at CFA access site angiography and contra-
lateral CFA angiography. It is also an excellent landmark to know during antegrade
access of the SFA.In the absence of optimal CFA vascular access during LE arterial
angiography, brachial or radial artery angiography can often, from the left upper
extremity, be accomplished with placement of pigtail catheter in the abdominal aorta
as close as possible to the aortoiliac artery bifurcation. Anticoagulation during diag-
nostic angiography is not routinely needed; however unfractionated heparinization is
recommended after placement of contralateral crossover sheath during a planned
intervention. If a staged SFA intervention is being planned following an initial diag-
nostic catheterization performed earlier, at least repeating a series of diagnostic
imaging of the SFA and BTK arteries is recommended to define the target lesion and
BTK runoff. Moreover, such imaging is highly recommended if diagnostic images
are suboptimal. Finally, attention needs to be directed to the profunda femoris artery,
especially to its origin as profunda femoris PAD is often contiguous with ostial and
proximal SFA and CFA atherosclerosis. It is vital to recognize that the profunda
femoris artery supplies most collaterals to the LE and distal FP and BTK vessels,
and avoiding injury, dissection or embolization, ostial plaque shift, or its obstruction
with stents, devices, or sheaths is important and may result in acute ischemia of the
LE and inadequate imaging of distal vessels. Early venous filling of the greater
saphenous vein (most commonly) or other veins is also important to note as congeni-
tal and post-traumatic or postoperative SFA arteriovenous fistulous communications
have been described, as have pseudoaneurysms of the SFA (Fig. 3.3).
Key Definitions Imaging of a SFA CTO begins with imaging of the proximal cap,
delineation of collateral vessels and side branches, especially at the proximal and
Superficial femoral
vein
Superficial femoral
artery
Arteriovenous
communication
Fig. 3.3Arteriovenous
communication during
SFA intervention.
Illustrates an arteriovenous
communication between
the superficial femoral
artery (SFA) and vein
following successful
recanalization of SFA
chronic total occlusion
distal cap and the shape of the caps: blunt versus tapered. A CTO by definition has
to be at least 3months old, and, in the absence of prior imaging, a clinical defini-
tion is used that includes the presence of an occluded SFA without filling defects in
the body of the occlusion to indicate more acute or subacute occlusion and no clini-
cal history of acute onset of LE symptoms or other signs of acute limb ischemia
(ALI) [3].
The key features of a FP CTO are indicated in Fig. 3.4. FP CTO length is defined
by angiographic distance between the proximal and distal caps, and lesion length
Proximal
cap
CTO body CTO Lesion

length length
Distal cap
Distal target
vessel
b Wire - catheter Crossing of SFA CTO
a b c
Guide catheter
Proximal cap
Side branch Guide wire
CTO body
Distal cap
Distal target
vessel
Fig. 3.4(a) Features of femoropopliteal CTO. (b) Femoropopliteal CTO crossing. (a) Parts of a
typical SFA CTO. (b) Inability to direct the wire in a SFA CTO. (c) Formation of a wire loop and
passage advanced through the subintimal space. Arrow head indicates the width of the wire loop
and the size of the potential subintimal space created
additionally includes any angiographic 70% diameter stenosis compared to the ref-
erence vessel segment. A single CTO is defined by angiographic 100% occlusion or
sequential occlusions separated by 2cm in the SFA and popliteal arteries or a single
occlusion separated by 1cm in BTK arteries. Vascular calcification visible on angi-
ographic views prior to contrast injection is classified as mild (isolated foci of calci-
fication), moderate (contiguous segments of calcification on one or a lternating sides
of the vessel), or severe (contiguous calcification on both sides of the vessel) [4].
Outcome measures include crossing success, procedure success, complications,
and major adverse events (MAEs). Crossing success is defined as placement of a
guidewire in the distal true lumen, past the distal CTO cap, confirmed by either
angiography or intravascular ultrasound (IVUS) [4]. Crossing success can be pri-
mary (achieved with the initial CTO crossing strategy) (Fig. 3.5), secondary (failed
initial strategy and subsequent success with an alternate device), or provisional
(subintimal passage of the initial crossing device necessitating the use of a special-
ized reentry device). Procedure success is defined as successful revascularization of
the CTO with 30% angiographic residual diameter stenosis [4]. Periprocedural
complications included flow-limiting dissections, arterial perforations, access site
hematomas 5 cm in diameter, retroperitoneal hematomas, distal embolization,
major bleed requiring blood transfusion, or emergency surgery. MAE included all-
cause mortality, nonfatal myocardial infarction, ischemic stroke, and unplanned
endovascular or surgical revascularization/amputation of the target limb [5].
Procedure Plans Planning a FP CTO procedure requires recognition of patient,
angiographic, and technical factors. Most FP CTO interventions are planned based
on contrast angiographic images; however DUS, CTA, and/or MRA images can
provide useful information that can often help the operator during case planning.
Primary technical success

Secondary CTO-crossing
technical device
success
FP-CTO Wire-catheter
Crossing
Provisional technical success
Fig. 3.5 Femoropopliteal CTO crossing strategies. Procedural success: successful revasculariza-
tion of the CTO with a 30% residual diameter stenosis (My own figure from journal: needs
copyright transfer JEVT)
Patient factors in FP CTO procedure planning include: symptom status, body

habitus, renal function, chronic anticoagulation status, prior lower extremity vas-
cular surgery or intervention, and compliance with medications, especially dual
antiplatelet therapy (DAPT). Contralateral CFA access with retrograde sheath
placement for SFA CTO intervention is the most common access with patient in
supine position. Antegrade CFA access, although an attractive alternative as it
reduces the distance to the FP CTO lesion, is technically more challenging espe-
cially in obese individuals, is associated with significantly higher vascular access
complications, and requires repositioning and/or reorientation of the patient and
equipment in the catheterization laboratory or vascular suite. It should be per-
formed by experienced operators and after careful evaluation of the surface anat-
omy and preferably under ultrasound (US) guidance with micropuncture needle.
For popliteal artery (PA) access, the patients should remain supine, with the lower
extremity in a 60 external rotation and the knee in a gentle flexion. An angiogram
via the proximal sheath should be performed to confirm the suitable level for dis-
tal PA puncture. In accordance with the standard surgical approach for the distal
PA, the puncture site should be determined beforehand 810cm below the border
of the medial condyle of the femur and parallel with the posterior medial border
of the tibia for 1cm. Puncture should be performed with a 21-gauge micropunc-
ture needle (Cook, Bloomington, Ind), obliquely from caudal to cranial. The
C-arm should be adjusted for precise alignment with the axis of the puncture
needle. Puncture is best performed under fluoroscopic guidance during live con-
trast. When access is obtained within the true lumen of the PA, a 0.018-inch V-18
guidewire (Boston Scientific, Natick, Mass) could be inserted, and the needle is
pulled out.
For retrograde puncture of the distal right SFA, the C-arm has to be brought to a
left anterior oblique position, and the needle has to form a line with the artery. To
check the distance of the needle tip to the artery during puncturing, the C-arm
should be brought into a right anterior oblique position at a 90 rotation from the
previous one. Retrograde access should be obtained distal to the adductor canal. A
V-18 Control guidewire could be passed through a 7-cm-long, 21-G needle.
Vascular and Lesion Access A 6 or 7F vascular access sheath inserted from con-
tralateral common femoral access is most frequently employed for treating SFA
CTO lesions. The sheath tip should be placed close to the SFA-popliteal artery
bifurcation to provide maximum support for crossing catheters and guidewires. As
one approaches a SFA CTO, there are numerous factors one could consider: pre-
senting symptoms, lesion location, length, calcification, character of proximal and
distal cap, collateral vessels, prior stent without fracture, multilevel occlusions, and
distal vessel disease and flow. Figure 3.6 outlines four key steps that need to be
defined prior to approaching a FP CTO lesion: lesion, approach, device, and strat-
egy. Among all factors that should be considered, lesion length, features of the prox-
imal cap, and level of distal reconstitution are most defining in outlining a crossing
strategy and selection of crossing device [6]. Figure 3.7 depicts a simple classifica-
tion of FP CTO lesions based on these key determinants and provides a guide to an
1. Define lesion XLPAD CTO Classification
2. Define approach Antegrade, retrograde, hybrid
3. Define device Wire-catheter, CTO crossing device
4. Define strategy
Fig. 3.6 XLPAD approach to femoropopliteal CTO: four key steps
Ambiguous proximal cap

&/or reconstitution at or Type IIIA Type IIIB Type IIIC
below P2-3
Tapered proximal cap +

reconstitution at or Type IIA Type IIB Type IIC
below P2-3
Tapered proximal cap Type IA Type IB Type IC
Length <50 mm Length 50-100 mm Length >100 mm
Antegrade Antegrade or retrograde approach Retrograde
Fig. 3.7 Femoropopliteal CTO classification and initial crossing approach (Adapted from:
Mustapha etal. [7])
initial crossing approach. Type I lesions have a tapered proximal cap that is most
favorable for crossing device or guidewire engagement. Such lesions are classified
as Type I lesions with Types IA, IB, and IC designating increasing CTO lesion
lengths from <50mm, 50100mm, and >100mm, respectively. Type IA and IB can
be approached antegrade with a guidewire-catheter or wire-catheter (WC) approach
(Fig. 3.8). This systematic approach to tackle FP CTO lesions was first introduced
by Mustapha etal. and was published as an abstract in 2014. We have modified it to
include crossing device selection. For Type IC lesions, an antegrade or a retrograde
approach should be considered, and a CTO crossing device (CCD) is preferred over
WC in the presence of heavy fluoroscopic calcification. Detailed description of
CTO crossing devices is provided in a dedicated chapter of this publication (Chap.
6). Careful attention to device, sheath and guidewire compatibility, should be paid
prior to selection of a crossing strategy. Although comparative assessments of CCD
and/or WC are absent, these recommendations are based on best-practice descrip-
tions and consensus opinion. Type II lesions have a tapered proximal cap, however
reconstitute at or below the P2P3 arterial segments of the popliteal artery. Again,
types IIA, IIB and IIC designate <50 mm, 50-100 mm, and >100 mm CTO lengths,
respectively. Type IIA CTOs are likely to be accessed via an antegrade approach
Ambiguous proximal cap

&/or reconstitution at or
Type IIIA Type IIIB Type IIIC
below P2-3 (WC); (CCD)* (WC); (CCD)* (WC); (CCD)*
Tapered proximal cap + Type IIA Type IIB Type IIC

reconstitution at or (WC) (WC); (CCD)* (WC); (CCD)*
below P2-3
Type IA Type IB Type IC

Tapered proximal cap
(WC) (WC) (WC); (CCD)*
Length <50 mm Length 50-100 mm Length >100 mm
Antegrade Antegrade or retrograde approach Retrograde *Heavy calcification

WC: wire-catheter; CCD: CTO crossing device
Fig. 3.8 Femoropopliteal CTO classification and crossing device selection (Adapted from:
Mustapha etal. [7])
Fig. 3.9 Transcutaneous ultrasound-guided ostial SFA CTO crossing technique. CFA common
femoral artery, CFV common femoral vein, PFA profunda femoral artery, SFA superficial femoral
artery, CTO chronic total occlusion, FR frontrunner CTO crossing device (My own figure from
journal: needs copyright transfer CRM)
predominantly with WC strategy; however Type IIB and IIC lesions could be
crossed with WC or CCDs via antegrade or retrograde access points. Again, CCD
should be preferred for heavily calcified lesions. FP CTO lesions with an ambiguous
proximal cap and distal reconstitution involving below-the-knee vessels are particu-
larly challenging and are classified as Type III FP CTO.Given the ambiguity of the
proximal cap, a primary retrograde approach should be favored. For ostial SFA flush
occlusions with no identifiable angiographic nub or proximal cap, a transcutaneous
ultrasound-guided CTO puncture technique could also be used (Fig. 3.9).
Selection of guidewires and support catheters can be based on some basic princi-
ples. Polymer or plastic sleeves are applied on guidewires to enhance lubricity and
reduce friction. These sleeves are designed to facilitate smooth tracking of the
g uidewires and improve lesion crossing. Guidewires also have applied coatings.
Hydrophobic coatings are typically silicone based and repel water while enabling
stronger tactile feedback. This tactile feedback is crucial during FP CTO crossing and
required for navigating guidewires and maintaining an intraluminal course. Thus,
hydrophobic guidewires have a lower tendency for subintimal passage. Guidewires
with hydrophilic coatings that attract water and create a lubricious gel-like surface
provide much lower friction and better trackability. These guidewires are best
employed to navigate tortuous and severely stenosed vascular segments with minimal
disruption of intraluminal thrombi. However, because these guidewires provide very
limited tactile feedback, tend to loop, and easily dissect their way into the subintimal
space, they are preferred during an intentional subintimal passage of the guidewire
generally supported with a microcatheter. Tables 3.1 and 3.2 provide guidewire and
support catheter options that are frequently employed in crossing FP CTO lesions.
FP CTO Crossing Strategies The intraluminal or IL FP CTO crossing technique
is the most frequently employed, at least initially. A 0.014-, 0.018-, or 0.035-inch
hydrophilic wire is frequently used in combination with a support catheter or a
CCD.It is important to remember here that many CCDs require a 0.014- or 0.018-
inch guidewire. A 0.035-inch guidewire and a compatible microcatheter with a
straight or angled tip are most frequently used. The operator has to depend on tactile
feedback provided by the WC combination and has to navigate based on the per-
ceived course of the vessel based on fluoroscopic calcifications, collateral filling of
a section of the vessel, and/or distal reconstitution. The catheter tip is maintained at
close proximity to the wire tip, and care is taken not to allow the guidewire tip to
Table 3.1 Guidewire options for femoropopliteal CTO intervention
Boston Scientific Cook Cordis Abbott Terumo Asahi

Journey Approach 6 Command Miraclebros
Increasing tip penetration
V-14 Approach 12 Pilot Confianza

0.014
Victory Approach 18 Astato XS 20
Approach 25
V-18 Connect Astato 30
0.018 Victory Connect Flex
Treasure Connect 250T
Glidewire
0.036
Advantage
Grey: Standard hydrophilic guide wires Typical wire escalation strategy:

Green: Preferred CTO guide wires for FP CTO Treasure 12 Astato XS 20 Astato 30/Approach 25
Table 3.2 Support catheters for femoropopliteal CTO intervention

Boston Vascular
Scientific Cook Bard solutions Medtronic Spectranetics Terumo
0.014 Rubicon Seeker Minnie Trailblazer Quick-cross
0.018 Rubicon CXI Seeker Minnie Trailblazer Quick-cross
0.035 Rubicon CXI Seeker Minnie Trailblazer Quick-cross Navicross
loop and dissect into the subintimal space [8]. Often, dilation of the proximal seg-
ments of the FP CTO may be required with a compatible undersized balloon to
decrease friction and facilitate advancement of the support catheter over the guide-
wire. Intravascular ultrasound (IVUS) may be used to confirm intraluminal or sub-
intimal location of the guidewire when the course is unreliable. In difficult to
penetrate locations, a laser catheter may be used to ablate IL debris, and the guide-
wire is replaced either by a CCD with or without microcatheter support or by a
hydrophilic looped wire technique used to traverse the lesion through a subintimal
tract. Confirmation of distal vessel true lumen entry can be obtained with (a) free
passage of the guidewire into the distal vessels, (b) contrast injection proximally or
through the microcatheter following distal pressure recording, (c) easy aspiration of
blood, (d) or by IVUS.IVUS should be preferred in difficult to cross lesions as it is
most reliable and provides crucial information, not only about the location of the
distal guidewire tip but also about the course of the guidewire along the body of the
CTO. This information can be crucial in determining the subsequent treatment
course, especially if debulking of the lesion with an atherectomy catheter is planned.
Contrast injection through the microcatheter tip advanced across the distal CTO cap
should be discouraged as it can be unreliable and, in rare situations, can propel dis-
tal hydraulic dissection and contrast staining of the interventional area making con-
tinuing with the procedure quite difficult.
The subintimal or SI technique is to proactively manipulate the WC to create a
neolumen between the intimal and adventitial layers of the arterial wall. SI dis-
section technique is best employed with a 0.035-inch hydrophilic guidewire and
compatible microcatheter [9]. The microcatheter is butted against the vessel wall or
point of resistance, and the hydrophilic guidewire is advanced to create a loop. The
catheter tip should be kept a short (1020mm) away from the guidewire, and both
should be advanced in unison to maintain a narrow guidewire loop size that can be
freely advanced along the SI space and perforate spontaneously back into the true
lumen in the majority of cases at or beyond the distal reconstitution of the FP
CTO.In about a third of cases, a specialized SI reentry device is needed to puncture
a tract from the SI space into the true lumen of the distal vessel. The reentry device
is generally delivered over the guidewire placed in the SI space, and it is recom-
mended that a fresh guidewire be passed into the true lumen through the reentry
device. Some devices, like the Enteer, require a specialized preshaped wire with
a probe for reentry (Stingray). It is not uncommon that the subintimal tract is
predilated with an undersized (generally 2.0mm) balloon to facilitate delivery of
more bulky reentry devices like the Outback or OffRoad. Following successful
distal vessel reentry, the reentry site needs to be optimally predilated as it may offer
greater than expected resistance to delivery of larger sized balloons or stents.
IL CTO crossing is an easily acquired skill set and is the most commonly used
CTO crossing method. It is an easy transition from crossing highly stenotic lesions
and a well-understood translation for the interventionist. Furthermore, the procedural
costs are quite low and limited to a standard guidewire and crossing catheter. Problems
associated with the IL technique are that it is not uniformly successful and may require
conversion to SI angioplasty to achieve a technically successful crossing. Without
concurrent imaging, it is also difficult to know whether CTO crossing remains truly
IL or the guidewire does not veer off segmentally into SI channels. Because of the
amount of IL material, there is a frequent need to add adjunctive therapy other than a
standard angioplasty balloon. This may require the addition of atherectomy devices or
scoring balloons to debulk or modify the plaque. Stents may also be required to main-
tain an adequate flow channel. Unlike IL crossing, SI CTO crossing utilizes a WC
approach that is significantly lower in cost compared to specialized CCDs. However,
SI technique has a steeper learning curve and requires greater experience and training.
In a third of SI cases, a specialized reentry device is required to reach the distal true
lumen. Failure to reenter the true lumen is the most common cause of failure of this
technique. Moreover, SI passage may also limit use of atherectomy catheters and is
overall associated with higher complication rates, including perforation and loss of
collateral vessels. Stenting is generally needed to secure SI crossing of FP CTOs.
3.1 Retrograde FP CTO Intervention
Crossing FP CTO via antegrade approach can be unsuccessful despite use of dedi-
cated CCDs. Retrograde access could then be used to traverse the occluded seg-
ment. Retrograde access to the SFA can be obtained via the popliteal or pedal
arteries [10]. Popliteal artery access requires the patient to be positioned in a prone
position. It can be uncomfortable for the patient and inconvenient to implement dur-
ing an ongoing procedure. Pedal access for retrograde FP intervention may provide
marginal support and can be limited by the lengths of equipment available to treat
the FP CTO. An alternative retrograde femoral artery approach that allows the
patient to remain in a supine position has been described. For retrograde approach
via the distal SFA, a 21-G at least 15-mm needle is recommended to penetrate the
medial and ventral aspect of the patients lower inner thigh corresponding to the
SFA distal to the adductor canal. The puncture is performed under fluoroscopic
guidance, and contrast injection through the sheath tip placed in the ipsilateral com-
mon femoral artery or proximal SFA may be needed. The C-arm should be first
positioned in a contralateral oblique (3045) position. For the right SFA, the
C-arm should be in a left oblique position and vice versa. After making the puncture
and advancing the needle through the thigh muscles, the C-arm should be moved to
a 90 orthogonal position to confirm whether the needle is in line with the SFA
when it is opacified with contrast. Once a coaxial position is confirmed, puncture of
the distal SFA should be performed. After successful puncture, a 0.018-inch guide-
wire (V-18 Control; Boston Scientific, Natick, MA, USA) could be inserted through
the needle followed by a 4 or 6F, 10-cm sheath (Terumo) or dedicated support cath-
eter. Generally, a support catheter can be advanced retrograde through the occluded
segment. In rare situations, a sheath needs to be inserted through the retrograde SFA
puncture for delivery of CCDs. If advancement into the true lumen is not possible,
a double-balloon inflation over antegrade and retrograde wires is advised to disrupt
dissection planes and create a channel for antegrade or retrograde guidewire
Table 3.3 Factors for consideration during retrograde femoropopliteal CTO intervention
Clinical consideration Anatomical consideration Relative contraindications
Patients presentation with Adequate distal SFA, Last remaining below-the-knee
critical limb ischemia popliteal or tibial or pedal vessel in claudicants
arteries
Long (100mm) or multilevel Patients with adequate Patients with contraindications
femoropopliteal CTO anterior and posterior to anticoagulation or arterial
communicating circulation vasodilator drugs
of the feet
Distal reconstitution of Favorable distal CTO cap Absence of detectable adequate
femoropopliteal CTO at or morphology caliber below-the-knee arteries
below the P2P3 segment of the
popliteal artery
Patients with hostile groin Inability to insert a sheath (may
access (extensive scarring, place retrograde guidewire to
morbid obesity, groin infection mark distal CTO target)
or wound), unable to lay flat
advancement into the true lumen of the SFA.Following access of the guidewire into
the true lumen, externalization and preferably antegrade delivery of balloons and
stents is necessary to complete the CTO recanalization procedure. A comparison of
antegrade and retrograde FP intervention is depicted in Table 3.3. Generally, the
retrograde access catheter can be removed and pressure applied externally to achieve
hemostasis. Occasionally, balloon occlusion of the SFA puncture site over a guide-
wire placed within the vessel is needed. A case of anterior tibial artery and retro-
grade SFA stent puncture is depicted in Fig. 3.10a, b.
3.2 T
ranscutaneous Ultrasound-Guided Endovascular
Crossing ofFP CTO
3.2.1 Peripheral Arterial Segments
Crossing of long and complex infra-inguinal arterial CTO presents a significant

challenge, and inability to remain intraluminal or reenter the true lumen after
subintimal dissection is the main reason for procedural failures and complica-
tions. A novel technique has been described for endovascular crossing of complex
infra-inguinal CTOs using frontrunner blunt microdissection (FR) with transcuta-
neous ultrasound guidance (TUG) [11]. The technique was used to cross two long
SFA CTOs (left, 300mm; right, 140mm) in patients with chronic kidney disease.
TUG allowed: (a) accurate visualization of occluded SFA segments (Fig. 3.9) and
the echo-reflective FR catheter, (b) directional control and safe intraluminal
manipulation of FR avoiding subintimal entry, (c) confirmation of distal true
lumen access, and (d) hemodynamic assessment after stenting. The above were
a
A B C D
b
A B C D
Fig. 3.10(a) Retrograde anterior tibial artery CTO intervention of the SFA. (A) Illustrates anterior
tibial artery access and insertion of 6F sheath (1) over 0.018-inch guidewire (2); (B) sheath in
anterior tibial artery; (C) a leading 0.014-inch crossing catheter (3) advanced in retrograde fashion
through the distal popliteal artery CTO cap supported with an appropriate guidewire; (D) dilation
of the subintimal tract with balloon (4) to facilitate retrograde entry of the guidewire into true
lumen. (b) Retrograde SFA stent puncture. (A) Illustrates stent fractures in the superficial femoral
artery or SFA (bold arrows); (B) medial thigh puncture with microneedle (1) and 0.018-inch guide-
wire (2) advanced into the distal SFA (C); SFA angiogram via 6F sheath inserted in the distal SFA
via retrograde medial thigh puncture of the SFA (D); Distal SFA angiogram with contrast injection
through retrograde sheath (3)
achieved with minimal use of fluoroscopy and radiocontrast administration. This

novel, simple, and reproducible technique can improve both the success and safety
of endovascular intraluminal crossing of infra-inguinal arterial CTOs: TUG-CTO
technique.
3.2.2 Transcollateral Approach toFemoropopliteal CTO
Presence of a large collateral at the proximal cap often makes penetration of the cap
challenging. The crossing device or guidewire tends to slip into the collateral vessel
and can also cause its dissection or perforation. Moreover, SI approach in the
presence of a large collateral vessel at the SFA CTO proximal cap includes the risk
of losing flow in the collateral. This is especially critical in the setting of an ostial
SFA CTO with profunda femoral artery supply to the distal limb. A transcollateral
approach to penetrate the distal CTO cap and either to cross retrograde, provide a
distal target, or create a dissection plane with transcollateral small balloon delivery
and distal cap angioplasty can facilitate crossing success [12]. A 0.014-inch 300-cm
guidewire Asahi Fielder wire (Abbott) and a 0.14 Quick-Cross catheter are gener-
ally best for traversing the collateral vessel. Selective injection can then be per-
formed of the collateral vessel through the Quick-Cross. The Fielder wire is then
advanced to the distal CTO cap the 0.14 Quick-Cross moved to the distal SFA CTO
cap over the guidewire. At this point, the Fielder wire can be switched to a Confianza
Pro 12 guidewire (Abbott) to penetrate the distal cap. The Treasure 12 wire (Boston
Scientific) can also be used to penetrate the cap. If attempts to advance the guide-
wire via the retrograde transcollateral approach are not possible, a small balloon
(2.0 100 Coyote balloon, Boston Scientific) could be advanced via the collateral
into the lesion in a retrograde manner. Following predilation via a retrograde
approach, a soft guidewire can then be advanced distally from the antegrade
approach.
3.2.3 SAFARI Technique
The SAFARI or subintimal arterial flossing with antegrade-retrograde interven-

tion is a technique for recanalization of FP CTOs that can be employed when sub-
intimal angioplasty is unsuccessful and retrograde access is feasible [13]. Retrograde
access is usually obtained via the popliteal, distal anterior tibial artery, dorsalis
pedis, or distal posterior tibial arteries.
3.2.4 Hybrid Approach toFemoropopliteal CTO Intervention
An optimal approach to FP CTO intervention involves thorough evaluation of base-

line angiogram and the technical ability and expertise to switch from one technique
to another. The hybrid approach to FP CTO intervention outlines some basic prin-
ciples that need to be considered and employed to achieve reproducible success in
crossing FP CTOs. The hybrid approach described here is based on an expert con-
sensus and needs to be validated by ongoing research in this area. The goal of devel-
oping the hybrid approach is to demystify the procedure and make its underlying
principle reproducible so that the broader interventional community can adopt it. It
is also important to recognize that most CTO procedures of the SFA should be
planned in advance and ad hoc intervention of FP CTOs should be strongly discour-
aged. As has been outlined earlier in this chapter, the first step of a hybrid approach
to femoral popliteal CTO intervention is to clearly identify all sections of the
vascular anatomy. This can be achieved by delayed imaging of the distal reconstitu-
tion of the SFA or popliteal arteries or by dual injections simultaneously from proxi-
mal and distal vessels or via collateral vessels. An antegrade approach with guidewire
escalation along with a support catheter is the first step when the proximal cap is
tapered and favorable for penetration. The presence of a blunt cap, large collateral
vessel, heavy calcification, and/or fractured stent would require consideration of a
retrograde approach. Figure 3.11 depicts the hybrid approach to FP CTO.For long
FP CTO, the antegrade WC approach may render the guidewire in the SI space.
There are a few techniques that the operator should be aware of when accessing the
distal true lumen. Similarly, there are retrograde dissection-reentry techniques.
These techniques are outlined in Fig. 3.12. As part of an antegrade approach, the
looped guidewire could be advanced through the dissection plane till it enters the
distal true lumen as part of the subintimal tracking and reentry technique or STAR
technique. Although this technique is easy to execute, especially if the guidewire
Ambiguous ca
ISR + Stent fracturep
Popliteal artery CTO
Tapered cap Femoropoliteal CTO
Appropriate distal access vessel
Claudication or CLI Assessment of cap
Appropriate interventional collateral
CTO length preferably <50 mm & run-off vessels
Primarily in CLI
1 2
Antegrade Retrograde
3 5 6 4
Wire-catheter Crossing device Crossing device Wire catheter
7 9 10 8
Antegrade Retrograde Retrograde true

Antegrade wiring
dissection re-entry dissection re-entry lumen entry
Fig. 3.11 Hybrid algorithm for crossing femoropopliteal CTO
Femoropoliteal CTO
Dissection-reentry
techniques
Antegrade Retrograde
Dissection Reentry Dissection Reentry
Controlled antegrade &

Looped wire Subintimal tracking & reentry Looped wire
Outback, Offroad, retrograde tracking Outback
Viance (STAR), Limited antegrade Viance
Enteer (CART/Reverse Stingray
Frontrunner subintimal tracking (LAST) Frontrunner
CART), Double balloon
Fig. 3.12 Dissection-reentry techniques for crossing femoropopliteal CTO

loop is kept narrow, it can and often will close off collateral vessels that may make
visualization of the distal reconstituted vessels poor as the case progresses if any of
the lost collaterals significantly contributed to distal vessel filling. A limited ante-
grade subintimal or LAST technique often relies on a more limited antegrade dis-
section and is therefore less likely to cause significant loss of collaterals. If the
above techniques fail, a dedicated reentry device should be used to reenter the distal
true lumen. The selection of the type of reentry device is often guided by the guide-
wire support, angulation of the iliac bifurcation, sheath size, diameter of the subin-
timal space, ability to track or predilate the subintimal space, and, finally, expertise
and familiarity of the operator. Use of dedicated reentry devices also contributes
significantly to procedure cost. Often, an IVUS catheter may be used to determine
the course of the guidewire and the point of its deviation into the subintimal space.
A more supportive reentry device like the Outback can also assist with a stepwise
approach from the dissection plane toward the distal true lumen by performing mul-
tiple successive reentries. From a retrograde approach, as described earlier in the
transcollateral technique, a balloon can be inflated in a retrograde dissection plane
communicating with the distal true lumen to facilitate antegrade passage of the
guidewire into the true lumen. This technique is called controlled antegrade-retro-
grade dissection/reentry or CART [14]. The CART technique can be applied to
dilate the antegrade dissection space and is referred to as the reverse CART tech-
nique. A double-balloon technique can also be used to dilate via both antegrade and
retrograde wires. However, care must be taken to not overlap the balloon tips that
should be kept at about 5 mm from each other. Operators, as part of the hybrid
approach, should be able to seamlessly switch from one technique to another. A
comparative assessment of antegrade or retrograde approach to FP CTO is presented
in Table 3.1. Tables 3.2 and 3.3 outline workhorse and preferred FP CTO guidewires
and support catheters, along with a recommended guidewire escalation strategy.
References
1. Banerjee S, Pershwitz G, Sarode K, Mohammad A, Abu-Fadel MS, Baig MS, Tsai S, Little
BB, Gigliotti OS, Soto-Cora E, Foteh MI, Rodriguez G, Klein A, Addo T, Luna M, Shammas
NW, Prasad A, Brilakis ES.Stent and non-stent based outcomes of infrainguinal peripheral
artery interventions from the multicenter XLPAD registry. J Invasive Cardiol.
2015;27(1):148.
2. Yang X, Lu X, Li W, Huang Y, Huang X, Lu M, Jiang M.Endovascular treatment for symp-
tomatic stent failures in long-segment chronic total occlusion of femoropopliteal arteries.
JVasc Surg. 2014;60(2):3628.
3. Banerjee S, Hadidi O, Mohammad A, Alsamarah A, Thomas R, Sarode K, Garg P, Baig MS,
Brilakis ES.Blunt microdissection for endovascular treatment of infrainguinal chronic total
occlusions. JEndovasc Ther. 2014;21(1):718.
4. Banerjee S, Sarode K, Patel A, Mohammad A, Parikh R, Armstrong EJ, Tsai S, Shammas NW,
Brilakis ES. Comparative assessment of guidewire and microcatheter vs a crossing device-
based strategy to traverse infrainguinal peripheral artery chronic total occlusions. JEndovasc
Ther. 2015;22(4):52534.
5. Banerjee S, Sarode K, Mohammad A, Gigliotti O, Baig MS, Tsai S, Shammas NW, Prasad A,
Abu-Fadel M, Klein A, Armstrong EJ, Jeon-Slaughter H, Brilakis ES, Bhatt DL.Femoropopliteal
artery stent thrombosis: report from the excellence in peripheral artery disease registry. Circ
Cardiovasc Interv. 2016;9(2):e002730.
6. Clark TW, Groffsky JL, Soulen MC. Predictors of long-term patency after femoropopliteal
angioplasty: results from the STAR registry. JVasc Interv Radiol. 2001;12(8):92333.
7. Mustapha JA, Saab F, Diaz-Sandoval L, McGoff T, Heaney C, Saad H.Chronic total occlusion
crossing based on cap morphology (C-TOP) in CLI patients: a pilot study and interim analysis
of the PRIME registry. Vascular Disease Management, September 2014, p.219.
8. Yilmaz S, Sindel T, Yegin A, Lleci E. Subintimal angioplasty of long superficial femoral
artery occlusions. JVasc Interv Radiol. 2003;14(8):9971010.
9. Fanelli F, Cannavale A. Retrograde recanalization of complex SFA lesions indications and
techniques. JCardiovasc Surg 2014;55(4):46571. Epub 2014 Jun 11.
10. Schmidt A, Bausback Y, Piorkowski M, Werner M, Brunlich S, Ulrich M, Varcoe R,

Friedenberger J, Schuster J, Botsios S, Scheinert D.Retrograde recanalization technique for
use after failed antegrade angioplasty in chronic femoral artery occlusions. JEndovasc Ther.
2012;19(1):239.
11. Banerjee S, Das TS, Brilakis ES.Transcutaneous ultrasound-guided endovascular crossing of
infrainguinal chronic total occlusions. Cardiovasc Revasc Med. 2010;11(2):1169.
12. Werner GS, Coenen A, Tischer KH.Periprocedural ischaemia during recanalisation of chronic
total coronary occlusions: the influence of the transcollateral retrograde approach.
EuroIntervention. 2014;10(7):799805.
13. Hua WR, Yi MQ, Min TL, Feng SN, Xuan LZ, Xing J.Popliteal versus tibial retrograde access
for subintimal arterial flossing with antegrade-retrograde intervention (SAFARI) technique.
Eur JVasc Endovasc Surg. 2013;46(2):24954.
14. Shi W, Yao Y, Wang W, Yu B, Wang S, Que H, Xiang H, Li Q, Zhao Q, Zhang Z, Xu J, Liu X,
Shen L, Xing J, Wang Y, Shan W, Zhou J.Combined antegrade femoral artery and retrograde
popliteal artery recanalization for chronic occlusions of the superficial femoral artery. JVasc
Interv Radiol. 2014;25(9):13638.
Chapter 4
Treatment ofFemoropopliteal CTO
SubhashBanerjee
The Trans-Atlantic Inter-Society Consensus (TASC) II class D femoral/popliteal

lesions include chronic total occlusions (CTOs) of the superficial femoral artery
(SFA) that are >20cm in length or involve the popliteal artery. Primary stenting has
proven superior to percutaneous transluminal balloon angioplasty (PTA) for FP
CTOs [1]. Table 4.1 provides an overview of currently recommended treatment
strategies of FP peripheral artery disease. Although surgical treatment may be pre-
ferred, current advancement of endovascular techniques and devices has made
peripheral vascular intervention (PVI) often the first-line approach. Overall there
are limited dedicated studies on stent versus non-stent approaches to FP CTOs.
Treatment strategies for long occlusions of the SFA following successful recanali-
zation have not been standardized, although these occlusions are frequently encoun-
tered in clinical practice. Stenting often leads to exaggerated neointimal hyperplasia
leading to high in-stent restenosis rates (1040% at 624months) and stent frac-
tures [2]. The subintimal approach can contribute to insufficient dilation and recoil
after stent placement in the subintimal space, whereas the response to balloon dila-
tion and self-expandable stenting can be more predictable and favorable with an
intraluminal approach.
Subintimal angioplasty is widely used for crossing of long CTO of the SFA with
favorable immediate and late outcomes. Despite the frequent use of subintimal
angioplasty for CTO lesions of the SFA, the role of stenting in the subintimal tract
is unclear. Hong etal. recently reported outcomes of spot stenting versus long stent-
ing after intentional subintimal approach for long chronic total occlusions of the
femoropopliteal artery [3]. A total of 196 limbs in 163 patients, implanted with bare
nitinol stents after subintimal approach in long femoropopliteal occlusions (lesion
length 25 8cm), were retrospectively analyzed. The primary patency was com-
S. Banerjee, MD
University of Texas Southwestern Medical Center and Veterans Affairs North Texas Health
Care System, Dallas, TX, USA
e-mail: subhash.banerjee@utsouthwestern.edu

42 S. Banerjee
Table 4.1 Treatment indications for lower extremity PAD lesions
TASC A
Single occlusion <5cm in length PVI
TASC B Multiple occlusions <5cm

Single occlusion <15cm not involving the PVI
infra geniculate popliteal artery preferred
Heavily calcified occlusion <5cm in length
TASC C Multiple occlusions totaling >15cm with or

without heavy calcification Surgery
Recurrent occlusions that need treatment preferred
after two endovascular interventions
TASC D
Chronic total occlusions of CFA or SFA
Surgery
(>20cm, involving the popliteal artery)
Chronic total occlusion of popliteal artery and
proximal trifurcation vessels
PVI peripheral vascular intervention

Norgren etal. [9]
pared between spot stenting (n = 129) and long stenting (n = 67). Adjusted-primary
patency (47% vs. 77%, p < 0.001) and adjusted freedom from target lesion revascu-
larization (52% vs. 84%, p < 0.001) at 2years were significantly lower in the long
stenting group than in the spot stenting group.
A complete intraluminal SFA CTO revascularization strategy may improve
patency rates and clinical outcomes relative to subintimal technique. Matsumi etal.
evaluated complete intraluminal angioplasty and self-expandable nitinol stenting for
TASC II D SFA CTOs in 72 consecutive limbs of 68 patients [6]. Mean CTO length
was 24.4cm and ~50% of patients had a single-vessel below-the-knee runoff. Primary
patency was 78% at 1year, 70% at 23years, and 52% at 5years. These patency rates
compare favorably to previously published patency rates in complex TASC II D SFA
lesions, reported to 60% at 1year, 2050% at 2years, and <50% at 3years.
Kruse etal. reported 5-year outcome of patients treated with self-expanding cov-
ered stents for SFA occlusive disease and identify parameters that could predict loss
of primary patency [7]. In this dual-center study, 315 consecutive patients (mean
age 69.010.1years; 232 men) were treated for SFA occlusive disease in 334 limbs
with VIABAHN self-expanding covered stents between 2001 and 2014 and retro-
spectively analyzed. Mean lesion length was 11.78.8cm. All-cause mortality at
5years was 14.1%. Primary patency rates at 1, 3, and 5years were 72.2%, 51.8%,
and 47.6%, respectively, with secondary patency rates of 86.2%, 78.7%, and 77.5%.
Covered stent diameter <7 cm was an independent predictor of loss of primary
patency.
The evidence of use of drug-coated stent in patients with TASC C/D de novo
femoropopliteal lesions is not conclusively in favor of stenting. In a recent single-
center registry, patients were prospectively followed by clinical and ultrasound
evaluation following FP CTO treatment with paclitaxel-coated stents. X-ray of
4 Treatment ofFemoropopliteal CTO 43
the stented zone was systematically performed 12months after implantation [6].
The primary endpoint was primary sustained clinical improvement after
12months. One year primary sustained clinical improvement rates for claudica-
tion/CLI patients were 68.0% 9.3% and 41.6% 11.1%, respectively (p = 0.13).
The incidence of in-stent restenosis and stent thrombosis was 25% and 14%,
respectively. The incidence of stent fracture was 12.5% per limb and 9% per
implanted stent.
In the 1-year results of paclitaxel-coated balloons for long femoropopliteal artery
disease (SFA-long study), the mean treated lesion length was 251 71mm, includ-
ing 63.4% moderate to severely calcified lesions and 49.5% total occlusions [7].
The bailout stent rate was 10.9%. Follow-up after 12months was obtained in 101
patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and
major adverse events had occurred in 7 (6.2%), with persistently significant clinical
benefits in Rutherford class.
Also, drug-coated balloons combined with spot stenting may be advantageous
for the treatment of long femoropopliteal CTO recanalization [8]. The placement of
a new self-expanding interwoven nitinol stent (SUPERA, IDEV Technologies,
Webster, Texas) or VIABAHN (Bard) may be another favorable option for the treat-
ment of popliteal lesions. Overall, a wide spectrum of endovascular treatment
options exists; the following successful FP CTO crossing (preferably intraluminal)
is achieved. These include PTA with conventional balloons, drug-coated balloons,
or specialty balloons (e.g., cutting, AngioSculpt scoring, or Chocolate balloons),
primary or bailout nitinol or drug-eluting stent implantation, interwoven nitinol or
PTFE-covered stents, and plaque modification by means of atherectomy. Despite
these options, high-quality randomized clinical trial, comparative effectiveness, and
cost-effectiveness data for treating FP CTOs are lacking, and specific studies in this
area are urgently needed.
4.1 F
ollow-up ofPatients FollowingSuccessful
Femoropopliteal CTO
4.1.1 Intervention
Although no formally tested recommendations are lacking, our own practice is

that patients should be observed at 1month after the procedure and then exam-
ined at 6-month intervals up to a year. Noninvasive hemodynamic evaluations
are repeated at 6 months and 1 year or if the symptom status deteriorates. At
least one imaging study, such as CT angiography, duplex ultrasound, or intra-
arterial angiography, is performed in the event of either a >0.15 decrement in the
ABI or worsening symptoms that were reflected by changes in the Rutherford
category.
44 S. Banerjee
References
1. Goetz JP, Kleemann M. Complex recanalization techniques for complex femoro-popliteal

lesions: how to optimize outcomes. JCardiovasc Surg. 2015;56:3141.
2. Kasapis C, Henke PK, Chetcuti SJ, etal. Routine stent implantation vs percutaneous translumi-
nal angioplasty in femoropopliteal artery disease: a meta analysis of randomized controlled
trials. Eur Heart J.2009;30:4455.
3. Hong SJ, Ko YG, Shin DH, Kim JS, Kim BK, Choi D, Hong MK, Jang Y.Outcomes of spot
stenting versus long stenting after intentional subintimal approach for long chronic total occlu-
sions of the femoropopliteal artery. JACC Cardiovasc Interv. 2015;8(3):47280.
4. Micari A, Vadal G, Castriota F, Liso A, Grattoni C, Russo P, Marchese A, Pantaleo P, Roscitano
G, Cesana BM, Cremonesi A. 1-year results of paclitaxel-coated balloons for long femoropop-
liteal artery disease: evidence from the SFA-long study. JACC Cardiovasc Interv.
2016;9(9):9506.
5. Davaine JM, Querat J, Kaladji A, Guyomarch B, Chaillou P, Costargent A, Quillard T, Gouffic
Y.Treatment of TASC C and D Femoropoliteal Lesions with Paclitaxel eluting Stents: 12month
Results of the STELLA-PTX Registry. Eur JVasc Endovasc Surg. 2015;50(5):6317.
6. Matsumi J, Ochiai T, Tobita K, et al. Long-term outcomes of self-expandable nitinol stent
implantation with intraluminal angioplasty to treat chronic total occlusion in the superficial
femoral artery (TransAtlantic Inter-Society Consensus Type D lesions). J Invasive Cardiol.
2016;28:5864.
7. Kruse RR, Poelmann FB, Doomernik D, Burgerhof HG, Fritschy WM, Moll FL, Reijnen
MM.Five-year outcome of self-expanding covered stents for superficial femoral artery occlu-
sive disease and an analysis of factors predicting failure. JEndovasc Ther 2015;22(6):85561.
8. Zeller T, Rastan A, Macharzina R, etal. Drugcoated balloons vs. drug-eluting stents for treat-
ment of long femoropopliteal lesions. JEndovasc Ther. 2014;21:35968.
9. Norgren L etal. Inter-Society Consensus for the Management of Peripheral Arterial Disease
(TASC II). JVasc Surg. 2007;45(Suppl S):S567.
Chapter 5
Endovascular Treatment ofBelow-the-Knee
AnandPrasad andFadiSaab
5.1 Introduction
With the aging of the US population as well as the epidemic of obesity, metabolic
syndrome, and diabetes, it is expected that lower extremity peripheral arterial dis-
ease (PAD) and specifically critical limb ischemia (CLI) will continue to be a major
healthcare challenge. Although a full discussion of the epidemiology and patho-
physiology of CLI is beyond the scope of this chapter, a few points will help provide
perspective for the reader. An important concept to convey is that the relationship
between diabetes and CLI is not casual, but rather causal in nature. The associations
between diabetic prevalence, complications, and mortality track closely with the
rates of CLI and of nontraumatic amputations. Over the course of a lifetime, a dia-
betic patient is significantly more likely to undergo limb loss than a nondiabetic
with over 60% of nontraumatic amputations being performed in diabetic individuals.
Although the pathophysiology leading to CLI in these patients is multifactorial
neuropathy, deformity, impaired immune response, and inflammation the role of
diffuse below-the-knee (BTK) atherosclerosis remains central to the failure of heal-
ing of foot ulcers. Traditionally, diabetic foot ulcers were classified as neuropathic
or ischemic in nature. We now know that 50% of neuropathic ulcers may have
impaired healing due to underlying ischemia. This ischemia is often microvascular,
but in many cases due to distal BTK disease involving the plantar circulation.
A term proposed to replace the traditional dichotomy of foot ulcer classification
and provide better emphasis on the pathophysiology is the neuro-ischemic ulcer
(Fig. 5.1) [1].
Given that progression of CLI to limb loss is multifactorial, a multidisciplinary
approach is key to successful outcomes. A team of individuals addressing diabetes,
infection, deformity, and wound bed care including hyperbaric therapy are needed.
A. Prasad, MD (*) F. Saab, MD

University of Texas Health Science Center, Department of Medicine,
Division of Cardiology, San Antonio, TX, USA
e-mail: anandprasadmd@gmail.com
46 A. Prasad and F. Saab
Diabetes mellitus
Polineuropathy Myelin
Autonomic Sensitive Motor Atherosclerosis
Medial calcification Muscular atrophy Peripheral vascular

(monckeberg sclerosis)
disease
Arterio-venous shunts
Hyperflux Posterior
opening
tibial
Pedall
Hot and turgid foot Insensible and deformed foot Cold and pale foot
Epidermal Foot Distal
Absence of pulses
cutaneous ischemla Pain insensebility seformation hipoperfusion
Biomechanical alteration
Extrinsic trauma
(ex shoes) Intrinsic trauma
(hyperpressure)
Ulceration Gangrene
Neutrophil dysfunction
Infection Infection
Neuroischemic
Neuropathic
Time
Fig. 5.1 Concept of the neuro-ischemic ulcer (From: Mendes and Neves [1])
However, a central tenant in CLI therapy is that despite supportive therapies a wound
is unlikely to heal without restoration of arterial circulation and conversely revascu-
larization alone without adequate wound care and risk factor modification may also
lead to suboptimal outcomes. The evaluation for the presence of ischemia is therefore
paramount in any foot ulcer which is new, recurrent, fails to heal, or stalls in its heal-
ing process. The objective assessment of ischemia in the context of CLI remains chal-
lenging and controversial and certainly again beyond the scope of this discussion.
Often multiple modalities including transcutaneous oximetry, skin perfusion pres-
sures, noninvasive anatomic imaging, and most importantly clinical judgment of
patient risk factors and history must be employed [2]. It is this authors belief that in
the appropriate clinical scenario a low threshold must be in place for using selective
catheter-based angiography to evaluate the lower extremity circulation particularly
the plantar vessels in patients with nonhealing foot ulcers [3]. Published data would
suggest that revascularization results in higher rates of limb salvage, reduced ulcer
recurrence, and perhaps reduced mortality as compared to conservative therapy [4,
5]. The decline in major amputations in the United States over the past decade has
been linked to the rise in revascularization for CLI particularly endovascular-based
therapies. Despite these data, the vast majority of Americans with PAD still undergo
a major amputation without angiography or attempt at revascularization [6].
5.2 BTK CTOs: Indications andTreatment Options
The presence of CLI remains the primary indication for revascularization of below-
the-
knee (BTK) vessels including recanalization of chronic total occlusions
(CTO). More controversial but potentially appropriate in specific situations is the
5 Endovascular Treatment ofBelow-the-Knee Chronic Total Occlusions 47
Table 5.1 Consensus statement of the Society of Cardiovascular Angiography and Interventions
for clinical scenarios in which treatment of infrapopliteal (IP) artery disease may be considered
Recommendation Clinical scenario
Appropriate care Moderatesevere claudication (RC 23) with two- or three-vessel IP
disease (if the arterial target lesion is focal)
Ischemic rest pain (RC 4) with two- or three-vessel IP disease (to provide
direct flow to the plantar arch and to maximize volume flow to foot)
Minor tissue loss (RC 5) with two- or three-vessel IP disease (to provide
direct flow to the plantar arch and to maximize volume flow to foot)
Major tissue loss (RC 6) with two- or three-vessel IP disease (to prevent
major amputation and to facilitate healing a minor amputation)
May be appropriate Moderatesevere claudication (RC 23) with two- or three-vessel IP
care disease (occlusion or diffuse disease)
Ischemic rest pain (RC 4) with one- or two-vessel IP disease (to provide
direct flow to the plantar arch and in two-vessel, to maximize volume
flow to foot)
Minor tissue loss (RC 5) with one-vessel IP disease (to provide direct
flow to the plantar arch and to maximize volume flow to foot)
Rarely appropriate Mild claudication (RC 1) with one-, two-, or three-vessel IP disease
care Moderatesevere (RC 23) claudication symptoms with one-vessel IP
disease
Major tissue loss (RC 6) with one-vessel IP disease
Table 5.2 The infrapopliteal lesion severity classification based on the Trans-Atlantic Inter-
Society Consensus (TASC) group
TASC
lesion type Description
Type A Single stenoses, 1cm in the tibial or peroneal vessels
Type B Multiple focal stenoses of the tibial or peroneal
vessels, each, 1cm in length
One or two focal stenoses, each, 1cm long, at the tibial
trifurcation
Short tibial or peroneal stenosis in conjunction with femoropopliteal angioplasty
Type C Stenoses 14cm in length
Occlusions 12cm in length of the tibial or peroneal
vessels
Extensive stenoses of the tibial trifurcation
Type D Tibial or peroneal occlusions >2cm
Diffusely diseased tibial or peroneal vessels
endovascular treatment of BTK atherosclerotic disease in the context of moderate to

severe claudication. Table 5.1 summarizes the current Society of Cardiovascular
Angiography and Intervention (SCAI) recommendations with regard to appropri-
ateness of treatment of infrapopliteal arterial disease [7].
The infrapopliteal lesion severity classification based on the Trans-Atlantic Inter-
Society Consensus (TASC) group is summarized in Table 5.2 [8, 9].
Unfortunately, the TASC II recommendations do not provide detailed informa-
tion on endovascular therapy for BTK lesions [10]. In addition, they fall short of
recognizing the diffuse nature of tibial disease. Patients with CLI and wounds
require direct in-line blood flow to the ulcer bed including often the plantar
c irculation. Traditionally, complex TASC lesions (C and D) including long CTOs

(>2 cm) or severely calcified and diffuse disease were the domain of surgical
bypass preferably with an autologous vein conduit. The debate between the two
forms of revascularization therapy reflects in part the somewhat counterintuitive
relationship between vessel patency and healing. Surgical bypass for BTK disease
has superior patency to angioplasty-based endovascular therapy; however limb sal-
vage rates are not significantly different between the two approaches [11, 12]. This
finding does not imply that long-term patency is not important, but rather that the
goal of wound healing can generally be achieved within 6months or less following
restoration of arterial flow [13].
The comparatively lower morbidity (compared to open surgery) and advent of
novel catheter-based techniques and technologies have encouraged many vascular
specialists to take an endovascular first approach to BTK disease [14]. There is a
paucity of randomized data in this context. The BASIL trial published in 2005 com-
pared angioplasty against surgical bypass in patients largely with CLI, and the
results supported the efficacy of a percutaneous approach with reduced morbidity
compared to surgery [12, 15, 16]. Longer-term follow-up of the data suggested a
mortality benefit in the surgical arm. However, often lost and relevant to this chapter
is that at the time of enrollment into the BASIL trial, 34% of patients had anatomy
not suitable for surgical or endovascular therapy. With advances in percutaneous
techniques including pedal approaches, dedicated wires and crossing devices, ather-
ectomy, and novel balloon c atheters, it is conceivable that many non-treatable
patients in older studies would now be candidates for therapy particularly for
modern endovascular modalities. This hypothesis will be tested, in part, with the
ongoing BEST-CLI study [17].
5.3 B
TK CTOs: Prevalence, Angiosome Concept,
andPathology
Any endovascular specialist treating patients with CLI will become intimately
familiar with CTOs. The prevalence of BTK CTOs in patients with CLI is 6070%,
and these occlusions are often coupled with multilevel disease (5060%) [18]. The
most common vessels which are occluded are the anterior and posterior tibial arter-
ies with frequent sparing of the peroneal artery [19]. When evaluating BTK dis-
ease particularly CTOs by angiography it is imperative to obtain high-quality
digital subtraction images. For this purpose, once above-the-knee (ATK) circulation
is evaluated, a catheter placed in the popliteal artery with injection of the BTK ves-
sels in orthogonal views is crucial. The imaging of the CTO stump, any islands of
contrast filling, the distal reconstitution, and status of the dorsal and plantar arches
(Fig. 5.2) are fundamental and may require selective cannulation of the individual
tibial vessels. We often use a long (150cm) 0.035/0.038 diameter support catheter
for this purpose and administer intra-arterial nitroglycerin prior to injections. It is
important to note that often injection through a retrograde sheath will provide imag-
ing of a vessel lumen which was not visible through antegrade contrast delivery
Fig. 5.2 Digital subtraction image of the pedal plantar circulation. Note the diffuse disease of the
posterior tibial artery, calcaneal branches, and dorsalis pedis arteries. The plantar circulation is
interrupted
(Fig. 5.3a, b). In this regard, simultaneous antegrade and retrograde injections can
also help define the CTO length and path.
Although perhaps less certain in the context of surgical bypass, the improved
outcomes with endovascular therapy over the past decade have been in part due to a
better understanding of the angiosome concept [20]. When evaluating BTK CTOs,
the vessel targets for therapy should be evaluated in the context of the angiosome
most likely to result in healing of the ulcer (Fig. 5.4). While indirect therapy is often
employed due to patient anatomy, a direct angiosome-based revascularization is
associated with improved limb salvage [21]. Failure of angiosome-directed therapy
for BTK CTOs can be multifactorial and include a poorly defined proximal or distal
cap, lack of pedal vessels for retrograde access, and heavy calcification.
a b
Fig. 5.3(a) Digital subtraction image of the distal anterior tibial CTO (dashed line). Image
obtained from antegrade injection. (b) Magnified image of same patient with retrograde injection
through 4 Fr sheath in the dorsalis pedis. Hibernating vessel lumen now visible with retrograde
injection (*)
The histopathology of BTK CTOs has important clinical ramifications and there-
fore warrants some mention. Calcification and diffuse disease both signatures of
BTK CTOs are common in diabetic patients and in those with chronic renal fail-
ure. Fluoroscopically, it may be challenging to distinguish medial (Monckebergs
calcification) from calcification involving luminal compromise. Both pathologic
studies and optical coherence tomography (OCT) studies of vessels taken from
amputated limbs have provided insight into the role of calcification [22]. As shown
in Fig. 5.5, BTK CTOs may have extensive circumferential calcification with com-
pression of the true lumen. This calcium deposition, in part, explains the rationale
Fig. 5.4 Angiosomes of the foot. DP dorsalis pedis artery angiosome, LP lateral plantar artery
angiosome, MP medial plantar artery angiosome, LC lateral calcaneal artery angiosome, MC
medial calcaneal artery angiosome (From: Alexandrescu and Hubermont [20])
OL
M
Ad
*
C
MC
C DL
Ad
MC
M
Fig. 5.5 Histologic cross sections of a heavily calcified below-the-knee CTO vessel. MC
Microchannels, C extensive calcification, OL occluded lumen, M media, Ad adventitia. The (*)
identifies an area of less dense tissue (collagen) surrounding the microchannel (From: Munce etal.
[22])
for atherectomy techniques to modify vessel compliance prior to angioplasty.

Beyond the proximal cap and cranial to the distal cap, microchannel(s) may exist
which are the endovascular targets of wire navigation. The true lumen surrounding
these microchannels has extensive lipid deposition and fibrosis with deposition of
smooth muscle cells and collagen. Less commonly thrombus often organized and
surrounding the microchannels may be present in the lumen of the BTK CTO.
5.4 BTK CTOs: Endovascular Approach
When a decision has been made to attempt endovascular therapy of a BTK CTO, the
case should be well planned out. The approach to the procedure can be summarized
in the following steps: access, crossing strategy, reentry, and treatment strategy.
5.4.1 Access
5.4.1.1 Access: Contralateral
The most common approach used to treat infrainguinal PAD remains contralateral
femoral access. While this access is comfortable to most operators and suitable for
many ATK lesions, several issues may arise when treating BTK CTOs using this
approach. Some of these concerns include sheath support for calcified lesions, bal-
loon and device length relative to patient height, and concerns over image quality
and excessive contrast use. If contralateral access is to be used, then a longer 55, 65,
or >70cm sheath is reasonable. When coupled with adequate anticoagulation (ACT
>200s) and intact inflow, the use of long contralateral sheaths in our experience has
been safe even when placed across the profunda femoris artery.
5.4.1.2 Access: Antegrade
Antegrade access provides many advantages over the contralateral approach includ-
ing substantially increased device support, ability to access distal vessels, and excel-
lent image quality. Traditionally, antegrade access was cumbersome and challenging.
With the use of ultrasound (US)-guided micropuncture cannulation, access success
can be improved greatly. Patient and operator comfort should be maximized during
antegrade access. Depending on the mobility of the imaging equipment and radia-
tion protection shields, the patient can be placed in a reversed supine position with
the feet under the flat panel and the head covered with a raised drape (tent) to
minimize claustrophobia. Our experience has found that medial angulation of the
micropuncture needle avoids bias into the profunda femoral artery and is more
likely to allow wire delivery to the superficial femoral artery (SFA). If the micro-
puncture wire favors the profunda and entry is at or above the common femoral
bifurcation, then a small microsheath can be placed into the profunda with the wire
kept in place. A second angled hydrophilic wire (e.g., V18 Control Wire, Boston
Fig. 5.6 Steps for antegrade access using the profunda femoris for support. (a) Micro-wire in
place in the profunda. (b) Sheath advanced on micro-wire. (c) Second hydrophilic wire advanced
into superficial femoral artery with the sheath retracted to the bifurcation
Scientific, Marlborough, MA) can then be used to wire the SFA as the sheath is
withdrawn back to the bifurcation (Fig. 5.6). The sheath with micro-dilator support
is then advanced over the V18 into the SFA and then exchanged for a larger sheath.
In general the use of a stiff 0.035 guidewire (Amplatz Super Stiff, Boston Scientific)
for support during sheath placement is helpful with the pannus retracted back by a
second operator or assistant. Although access is usually preferred in the common
femoral artery where compression can be achieved with manual pressure, access at
the junction of the CFA and SFA or even in the first cm of the SFA is acceptable and
lowers the risk of retroperitoneal bleeding. However, more distal access of the SFA
should be avoided due to the risk of bleeding into the thigh and potential for com-
partment syndrome. With the increased availability of extravascular closure devices
(e.g., Mynx, AccessClosure, Inc., Santa Clara, CA), closure of antegrade access
even involving SFA entry should be strongly considered.
5.4.1.3 Access: Retrograde Pedal Access
The option of retrograde pedal or distal tibial access should be considered when
planning a BTK CTO intervention, and comfort with this technique can increase
procedural success [23]. The rationale underlying retrograde access mirrors that of
Fig. 5.7 Ultrasound image of the dorsalis pedis artery. Arrow indicates vessel target
the CTO approach in the coronary circulation. The proximal caps of BTK CTOs
may not always be well defined or may be associated with a proximal collaterals
which can bias wires. The distal caps of BTK CTOs may in some cases be less
resistant to penetration as compared to proximal caps. Microchannels and vessel
islands may not be readily apparent with antegrade injection but can be seen with
retrograde injection as discussed earlier.
Visualization options for access include use of fluoroscopic landmarks coupled
with angiography or direct ultrasound-guided micropuncture. With the availability
of ultrasound-visible needles and handheld ultrasound systems, we recommend this
latter approach. The ultrasound scan of the target vessel should ideally be performed
with a high-frequency (715MHz) hockey stick probe (Fig. 5.7). Vessel diameter
(ideally 2mm), degree of calcification, and tortuosity should be evaluated. If pos-
sible, the access point should be sufficiently distal as to allow the sheath tip to be
several mm proximal to the distal cap. Common sites for access include the dorsalis
pedis, the PT just above the medial malleolus, and the distal AT above the ankle.
More challenging is access of the peroneal artery due to its deeper course and con-
cerns with hemostasis. Despite these issues, the peroneal artery can be accessed,
and awareness of potential bleeding should be kept in mind coupled with the avail-
ability of coronary diameter covered stents should hemostasis fail. Entry into the
artery can be facilitated if the foot is dorsiflexed and rotated out for the posterior
tibial and plantar flexed for the dorsalis pedis artery. The use of ultrasound also
helps inadvertent cannulation of the tibial veins. The flow in the distal tibial arteries
in CLI patients is often sluggish; therefore arterial flash back can be relatively
venous-like. The ultrasound relationship of the veins and arteries is reliable in that
a tibial artery is surrounded by one or more (often 23) veins in and the artery is
often calcified. The ultrasound probe should be rotated as necessary to see the tip of
the microneedle during access, and often steady slow pressure by the needle tip on
the arterial wall is required to penetrate the calcium and avoid rolling of the vessel.
Much like radial artery access, the use of excessive lidocaine should be avoided, and
use of systemic or intra-arterial nitrates can be helpful to minimize spasm.
If the distal anatomic target is poor, retrograde access can still be considered and
a micro-dilator only strategy for stability can be used. This type of access is primarily
used for retrograde wire passage. Preferably, the placement of a sheath allows for
secure access, easier interchange of wires and support catheters, and facilitates angi-
ography. Examples of available sheaths for pedal access include the Cook
Micropuncture Pedal Introducer Access Sheath (Cook Medical, Bloomington, IN),
(2.9 Fr inner diameter) and the Terumo Pinnacle Precision Access System Sheath
(Terumo IS, Somerset, NJ). The latter sheath has a true 4 Fr inner diameter and allows
for larger device passage. Once the sheath is in place, copious use of intra-arterial
vasodilators including nitroglycerin and calcium channel blockers is paramount. We
recommend fairly aggressive anticoagulation once the pedal sheath is in place with
ACTs 250 s. The sheath should be flushed regularly and secured with tape or a clear
adhesive covering. Removal of the sheath can be done with manual pressure or use of
a radial artery compression band for ankle level access. Hemostasis can generally be
achieved, even in the context of an elevated ACT if manual pressure is used. The tim-
ing of sheath removal varies upon the procedural approach. If the retrograde access
results in successful wire passage across the CTO and the wire is snared from above
and externalized with plans for antegrade treatment, then the sheath can be removed
prior to conclusion of the intervention with close observation of the pedal access site.
It is also helpful to keep in mind that if after successful treatment the flow in the target
tibial vessel appears sluggish, the presence of an indwelling distal sheath is a likely
cause and the flow should be reevaluated with the sheath pulled out.
5.4.1.4 A
ccess (and Treatment): Tibio-pedal Arterial Minimally Invasive
Retrograde Revascularization (TAMI)
Pioneered by Mustapha, Saab and colleagues, the tibio-pedal arterial minimally

invasive retrograde revascularization (TAMI) approach is a retrograde pedal or tib-
ial access technique for treatment of BTK disease (and in some cases more proximal
disease) [24]. The rationale behind the TAMI approach is to avoid femoral access
(either contralateral or antegrade ipsilateral) and therefore avoid the potential for
groin site complications, to improve crossing support and to allow for better distal
tibial vessel angiographic visualization. Access, pretreatment angiography, treat-
ment, and post-angiography in this technique is done exclusively through the retro-
grade access. Recently, there has been new equipment developed to deliver therapy
in the tibial and plantar circulation. The TAMI technique capitalizes on the ability
to deliver different types of balloons, atherectomy, and stenting options via a single
pedal sheath. The recent release of the slender sheaths (Terumo), 4/5 Fr, 5/6 Fr, 6/7
Fr, allows for multiple options of revascularization. Atherectomy devices that can
be placed though the 4/5 Fr access include orbital atherectomy (CSI Micro crowns
1.25, 1.25 solid, and 1.5 solid) and laser atherectomy up to 1.7mm catheter. Stent
options that can fit through the 4/5 Fr sheaths include the Abbott Xpert stents plat-
form and the non-drug-eluting Zilver stents (Cook Medical). It should be noted that
this is a rapidly evolving area, and equipment compatibility with pedal access
sheaths is expected to increase in the near future.
Paramount to the TAMI technique is maintenance of the patency of the pedal

access vessel. Infusion of a carefully de-aired heparinized vasodilator solution
(TAMI solution) into the side arm of the sheath helps prevent vasospasm or throm-
bosis. This solution consists of 3000 g nitroglycerin and 2.55 mg verapamil
mixed with 500ml of heparinized saline and infused into the arterial sheath at a rate
of 67 ml/min. The rate can be adjusted depending on the patients
hemodynamics.
Posttreatment imaging is done by placement of a small diameter catheter in the
proximal treated vessel connected to a Tuohy-Borst or Copilot system-type connec-
tion (Abbott Vascular, Santa Clara, CA) to maintain wire access and allow for injec-
tion. The TAMI technique has some drawbacks which warrant mention. It is limited
for multilevel disease treatment, cannot be used with directional atherectomy
devices (TurboHawk/Silverhawk, Medtronic, Minneapolis, MN) which require
antegrade directional cutting, and is best suited for treatment following true lumen
passage of the wire. In addition, filter embolic protection devices (EPDs) cannot be
used in the TAMI technique, although the presence and aspiration of the sheath in
the distal vessel may in theory provide protection to the foot vasculature obviating
need for an EPD.
5.4.1.5 Access: Metatarsal andDirect Pedal Loop
An intact pedal loop significantly aids in wound healing, and reconstruction of the
distal foot circulation can be approached in multiple ways. Direct access of arch/
pedal loop vessels is an option for retrograde recanalization particularly when
antegrade attempts have failed. This access is typically performed in concert with
ipsilateral antegrade access. Access of the pedal loop has been pioneered by Palena
and colleagues [25, 26]. Access into the pedal loop circulation is often best achieved
with puncture of the first dorsal metatarsal artery; alternatively direct access of the
loop itself may be considered (Fig. 5.8a, b). Given the small size of these vessels,
use of careful fluoroscopic or ultrasound-guided landmarks (calcification) to guide
access with copious pretreatment with vasodilators is key. Access is obtained with a
21 gauge microneedle and a microsheath is placed (Cook sheath, Cook Medical,
Bloomington, IN). It is not necessary or even possible in many cases to place the
entire length of the sheath in the access vessel rather once the sheath is several
a b
Fig. 5.8 Metatarsal access (a) and pedal plantar loop access (b) (From: Manzi and Palena [48])
millimeters in place, it can be secured to the foot with adhesive tape or transparent
film. Retrograde crossing can then be performed with 0.014 or 0.018 diameter
wires with crossing catheter support, with wire capture and treatment from the ante-
grade approach. The access site sheath can be removed with manual pressure held
or alternatively use of a small diameter (2.0 mm) balloon for tamponade. Again
given the size of the vessels involved, this approach which remains technically chal-
lenging is thus far limited to select centers. Palena and colleagues have noted an
acute technical success rate of over 84% without major procedural complications.
5.4.1.6 Access: Radial
There is an increasing interest in use of radial access for angiography and interven-
tion in patients with lower extremity PAD.Intervention thus far has been limited to
iliac and femoropopliteal disease, and at this time there is little role of radial in the
therapy of BTK disease [27]. Nonetheless long peripheral catheters (e.g., 150cm, 4
Fr Terumo PV catheter) are available and in shorter patients may provide a means
for obtaining diagnostic data if needed.
5.5 Crossing Approach
The choice of access, crossing approach, and treatment strategies are all interre-
lated. An understanding of catheter and device (balloon, stent, atherectomy catheter,
EPD) sizes and sheath compatibility is crucial to successful treatment of BTK
CTOs. Bailout strategies if one approach fails should be preplanned. Algorithmic
approaches to peripheral CTOs remain in development and as of yet are not as
robust as those for coronary CTOs [28]. The two broad approaches are a wire/sup-
port catheter technique versus a crossing device strategy. There are data which
would suggest that crossing devices may have superior technical success as an ini-
tial strategy compared to a wire-based approach in infrainguinal CTOs [29]. Over
the past decade, there has been an increase in the availability of crossing devices;
however there are no randomized data at this time to support one approach over
another in the BTK circulation. In addition the (non-reimbursed) cost of these tools
must be taken account when gauging their overall utility in the healthcare system. A
summary of current crossing tools is shown in Table 5.3.
Wire strategies have primarily revolved around use of coronary guidewires (3 to
12+ g tip weight) or heavier peripheral specific wires (18 to > 20 g tip weights in
either 0.014 or 0.018 diameters). Table 5.4 outlines selected wires for BTK CTOs.
Hydrophilic polymer-coated wires can be considered when a microchannel is
seen or suspected by angiography. Whether a wire escalation strategy or use of spe-
cific wires upfront is the superior method remains unclear, but in general heavily
calcified vessels require heavier tip weights. Whether using a crossing device or
wire approach, true lumen passage is attractive in the BTK for a number of reasons.
Table 5.3 Selected crossing devices and descriptions

Crossing device Manufacturer Description
Viance Covidien/Medtronic Blunt manual probing/controlled
dissection
Can be used retrograde
WildCat/KittyCat Avinger Manual or assisted blunt dissection
Ocelot Avinger Manual or assisted blunt dissection with
OCT guidance
Peripheral Crosser Bard High-frequency vibrations to penetrate
tissue
TruePath Boston Scientific Diamond-coated rapidly rotating tip
Frontrunner XP Cordis Blunt microdissection
Table 5.4 Selected wires and characteristics

Wire Manufacturer Characteristics
MiracleBros Wires, 0.14 Abbott/Asahi 312 g tip weight
Hydrophobic coated
Approach, 0.014 Cook 625 g tip weight
PTFE coated
Treasure 12, 0.018 Asahi 12 g tip weight
Hydrophilic tip coating
PTFE shaft coating
Astato 30, 0.018 Asahi 30 g tip weight
PTFE shaft coating
Astato XS 20, 0.014 Asahi 20 g tip load
PTFE shaft coating
True lumen passage allows for potentially more aggressive debulking with atherec-
tomy and avoids the use of stenting. As compared to the SFA bed, the data for infr-
apopliteal subintimal angioplasty are less robust, though several reports suggest
adequate clinical outcomes [30]. Certainly, long areas of subintimal passage can
result in impaired flow and often require adjuvant therapy with stents. The small
diameter and long length of BTK vessels also limit the choice of available stent
technology. General options to deal with subintimal wire or device passage are to
attempt reentry or use opposite direction access.
5.5.1 Reentry
True lumen reentry can be challenging again due to vessel size and calcification.
Reentry can be achieved with the use of a stiff angled wire and catheter method to
puncture into the true lumen, a needle-based technology such as the Outback
(Cordis, Fremont, CA) catheter system or a balloon orientation/penetration wire
Flat shaped self-orienting balloon
OTW 0.014* and 0.018

guidewire compatible
180* opposed
and offset ports
Fig. 5.9 Enteer reentry system. The flat-shaped balloon is inflated with 12 atm and reorients
itself in the subintimal space. A specific Enteer wire (stiff or standard) is advanced through the
balloon and is used to puncture into the true lumen
combination such as the Enteer (Medtronic) system (Fig. 5.9). The small profile of
this latter tool is particularly helpful at distal reentry in the tibial vessels; an example
of use of this device is shown in Fig. 5.10. The technique recommended is to
advance the Enteer balloon over the subintimal wire adjacent to the reconstituted
vessel. Although the balloon may appear adjacent to the true vessel, orthogonal
angulated views should be performed to confirm the position. When inflated the
Enteer balloon should lay out in a long cylindrical appearance generally no more
than 13 atm are needed to inflate the balloon. The subintimal wire can then be
removed and the micro-tapered Enteer wire (either stiff or standard) can be advanced.
Manipulation with a torque device should be performed of the Enteer wire such that
it exits the balloon through the side port directed toward the target vessel. We have
generally found that the standard wire below the knee is sufficient for reentry with
the stiff wire reserved for above the knee or heavily calcified tibial vessel use. Gentle
but steady focused pressure is often required to puncture the true lumen in cases of
calcification. Once the Enteer wire has entered the true lumen, it should be freely
mobile. Given the needle-like nature of this wire, it should not be advanced far
distally rather the balloon should be deflated, removed, and the Enteer wire
exchanged for a workhorse wire. Generally, avoidance of heavily calcified segments
is recommended for selection of a reentry zone.
5.5.2 Opposite Direction Wire Strategies
It is our preference to stay true luminal or at least keep the length of subintimal pas-
sage to a minimum for BTK CTO recanalization and therefore allow for adjunctive
atherectomy. The use of intravascular ultrasound can be helpful to determine the
a b c d
Fig. 5.10 Anterior tibial CTO. (a) A retrograde wire has entered into the subintimal space. (b) The
Enteer catheter (*) is advanced through the retrograde sheath. An antegrade catheter (arrow) marks
the true lumen. (c) Once the wire is in the true lumen, it is exchanged for a workhorse wire and
advanced. (d) The wire is snared and brought into the antegrade sheath
extent of subintimal passage, location of true lumen exit, and select segments which
can be treated with atherectomy. If a wire (or catheter) strategy results in entry into
the subintimal space (either from an antegrade or retrograde approach) and device-
assisted reentry is not used (or fails), then passage of a second wire in the opposite
direction can be attempted. The goal of this second wire is true lumen passage when
possible, but if not, a variety of subintimal space strategies including controlled
antegrade and retrograde tracking and dissection (CART) and subintimal arterial
flossing with antegrade-retrograde intervention (SAFARI) techniques can be con-
sidered. The CART technique involves inflation of a small diameter (2.0mm) over
the retrograde wire while trying to advance the antegrade wire located in the subin-
timal space into the true distal lumen. Reverse CART is the same technique with
reversal of the balloon inflation onto the antegrade wire when the retrograde wire
has entered the subintimal space (Fig. 5.11). The SAFARI technique has been
described in the tibial vessels, and akin to the knuckle technique in coronary CTOs
involves intentional entry into the subintimal space [30]. This entry is facilitated by
generating a looped tip on the guidewire and dissecting past the occluded segment
to join the subintimal space from an opposite wire. The entry into the subintimal
space on both ends is dilated with a balloon or catheter prior to definitive angio-
plasty. Though the data are relatively scarce, this technique is associated with an
adequate technical success rates (7080%); however given technological advance-
ments in true lumen crossing tools and reentry devices, the SAFARI technique is
less commonly used in contemporary practice.
Antegrade wire
Retrograde wire
Fig. 5.11 Reverse CART.Angioplasty over antegrade wire creates a space for advancement of the
retrograde wire
5.5.3 Wire Capture
If retrograde techniques will be used and antegrade treatment performed, then wire
capture will be required during the case (Fig. 5.12). The simplest (and most cost-
effective) method is to directly wire the antegrade sheath. Generally this is facili-
tated by a small loop at the tip of the wire and prolapse into the sheath. Alternatively
if a Viance catheter is used, this catheter when spun generally enters the sheath
without difficulty. Rarely, 2mm diameter snares (or multi-loop gooseneck snares)
can be used to externalize wires. The superficial femoral artery allows for the easi-
est deployment of snares without risk of injury to the smaller BTK vessels. In our
experience, snaring wires particularly 0.014 or 0.018 diameters requires some
time and patience. An alternative device is the Quick-Cross Capture catheter
(Spectranetics, Colorado Springs, CO), which is a balloon-supported funnel-shaped
wire capture device. Inflation of the balloon centers the funnel in the middle of the
vessel (generally used in the SFA), and the wire then has limited options but to enter
the funnel. Once in the device it is advanced through the length of the catheter and
easily externalized. When not using such a device or a snare, externalization of the
a b c
Fig. 5.12 Wire capture without snares. (a) A retrograde wire is advanced into the sheath. A loop
on the tip helps to knuckle the wire into the sheath. (b) A Spectranetics (Colorado Springs, CO)
Quick-Cross Capture catheter is advanced through the antegrade sheath. This catheter has a bal-
loon that when inflated centers the lumen of the catheter to the vessel. A funnel (see insert) at the
distal end of the catheter directs the wire into the lumen. (c) A Viance catheter (Medtronic) (arrow)
is advanced retrograde from a pedal sheath into the common femoral artery where it is directed into
the sheath by rapid torque delivery
wire can be challenging as the sheath hub must be removed and the wire pulled out.
This process may lead to blood loss from the sheath and reattachment of the hub
over the floppy end of the guidewire may be challenging. To minimize this issue, a
90cm 0.035 support catheter can be inserted into the sheath and the guidewire
advanced through the tip of the catheter and out of the sheath (Fig. 5.13).
5.5.4 Extravascular Ultrasound-Guided Crossing (EVUS)
The concept of using extravascular ultrasound-guided crossing (EVUS) represents

the natural evolution of using US in the endovascular lab. Traditionally, the use of
US has been reserved for obtaining access in vascular conduits including arteries
and veins. The use of US in obtaining access for variety of vessels has been exam-
ined by Mustapha, Saab etal. and has been shown to be safe and effective in obtain-
ing access across all vascular beds including tibial/plantar circulation [31].
a b
Fig. 5.13 Wire externalization without snare. (a) A retrograde 0.014 wire is advanced into the
contralateral sheath and fed into a 90cm 0.035 support catheter (arrow). (b) The wire is then
externalized (arrow) through the support catheter without need to manipulate the sheath hub
Fig. 5.14 Retrograde tibial

wire deflected to subintimal
plane by the tibial CTO
Wire
Sub-intimal Plane
Tibial CTO
EVUS allows the operator to visualize wires, CTO crossing tools, catheters,
atherectomy, and stenting devices and to direct their equipment in real time. Direct
visualization is particularly important as the operator is attempting to cross a
CTO.Knowing when the wire goes into a subintimal plane or extravascular space
has important implications on treatment decisions and options. Figure 5.14 shows a
retrograde CTO wire crossing from the true lumen into the subintimal plane. This is
a critical stage in the procedure as the operator may choose to obtain alternative
access or may consider the use of reentry devices. Furthermore, one may make the
argument that the EVUS approach may increase the safety of the procedure by
reducing radiation and the amount of contrast.
5.6 Treatment Strategies
5.6.1 Balloon Angioplasty
Percutaneous transluminal angioplasty (PTA) remains the mainstay of treatment for

BTK CTOs. Evaluation in balloon technology has resulted in improved crossing
profiles, longer shaft, and balloon lengths. In addition, tapered balloons are avail-
able which help approximate the natural size changes of tibial vessels [32]. In addi-
tion to 0.014 dedicated peripheral balloons, coronary balloons are frequently used
in the treatment of BTK disease and particularly in distal vessels which have
improved crossing ability as compared to their peripheral counterparts. Focal PTA
is often necessary at fibrotic or calcific spots prior to delivery of longer peripheral
balloons. The technique for PTA is similar to other vascular beds where a methodi-
cal gradual inflation at a 1:1 vessel to balloon ratio for several minutes (35min)
followed by slow deflation is recommended. Dissections are not uncommon but
with attention to technique, rarely flow limiting. With the concern for dissections
and the fibro-calcific nature of BTK plaque, there has been significant interest in
specialty balloons designed to score plaque or prevent intimal damage (Table 5.5).
Limited data would suggest that these balloons may result in fewer dissections, but
long-term efficacy data compared to traditional angioplasty is lacking. Apart from
dissections, the drawbacks of PTA are elastic recoil and neointimal hyperplasia. In
selected studies, the primary patency rates with PTA have been reported as low as
4050% range at 1 year, while other data would suggest patency rates up to 70% in
shorter lesions. However it should be kept in mind that wound healing rates, as dis-
cussed above, with PTA only approach are comparable to surgical bypass despite
higher restenosis. If a PTA approach is taken and there is stalled healing, restenosis
should be considered and the threshold for repeat angiography and intervention kept
low.
Table 5.5 Specialty balloons for BTK angioplasty

Balloon Manufacturer Description
Flextome Cutting Boston Scientific Noncompliant balloon with blades which score
Balloon plaque
AngioSculpt Spectranetics Helical nitinol scoring elements modify plaque
Chocolate TriReme Semi-compliant balloon in a nitinol cage which
distributes inflation forces along the balloon limiting
risk of dissection
5.6.2 Bare Metal Stents
The role of stenting for BTK disease has primarily been to treat flow-limiting dis-
sections or persistent elastic recoil. The relative smaller diameter of the tibial ves-
sels, coupled with their length, and often impaired outflow limit the role of extensive
stenting. The choices for bare metal stents include 2.04.0 coronary balloon expand-
able stents or 3.04.0 nitinol self-expanding stents (Xpert stents, Abbot vascular).
When balloon expandable stents are used in the context of CLI, the primary patency
and freedom from target lesion revascularization rates range between 5070%.
Nitinol self-expanding stents were studied by Rocha Singh etal. in the XCELL trial
[13]. The 6-month binary restenosis rate approached 70%, with clinically driven
freedom from TLR rate of 70.1% at 12months and 1-year wound healing rates of
54.4%. Though generally felt to be effective, these data in total suggest that bare
metal stenting is modestly better than PTA alone and highlight the challenges with
BTK vessel patency.
5.6.3 Drug-Eluting Technologies
Potentially, mitigating the impact of restenosis is delivery of anti-smooth muscle

proliferation therapy either by way of drug-eluting stents (DES) or drug-coated (pri-
marily paclitaxel) balloons. DES available widely for over a decade for the coronary
arteries have been studied in the BTK circulation. Single-center studies and regis-
tries have demonstrated excellent primary patency rates averaging in the 90% range
[33]. Randomized data including the YUKON-BTK trial, the ACHILLES trial, and
the DESTINY trial demonstrate similar results in terms of patency and freedom
from TLR [34]. Despite these data, DES are not a panacea for the treatment of
CLI.Limitations include the short lengths of available DES (38mm currently in the
United States) relative to lesion lengths (150200mm CTOs are common), cost of
placement of multiple DES, potential risk of stent thrombosis with potential need for
longer-terms antiplatelet therapy, impairment of landing zones for future bypass,
management of no stent zones near the ankle and near tibial plateau, and stents may
be a poor choice in many small diameter diffusely diseased vessel. For these reasons,
the use of DCB technology has gained much interest. Small pilot trials, including the
DEBATE BTK study (Drug-Eluting Balloon in Peripheral Intervention for Below-
the-Knee Angioplasty), demonstrated superior patency and lower restenosis rates as
compared to standard PTA [35]. A handful of larger trials are currently underway
examining the role of drug-coated (paclitaxel) balloons in the tibial circulation.
These include the LUTONIX BTK (Lutonix Drug-Coated Balloon Versus Standard
Balloon Angioplasty for Treatment of Below-the-Knee Arteries) and the BAIR trial
(Paclitaxel-Coated Versus Uncoated Balloon for the Treatment of Below-the-Knee
In-Stent Restenosis) [33]. The results of the Medtronic INPACT DEEP trial
(Randomized Study of IN.PACT Amphirion Drug-Eluting Balloon vs Standard PTA

for the Treatment of Below-the-Knee Critical Limb Ischemia) were recently pub-
lished [36]. The study demonstrated no significant benefit in terms of TLR or late
lumen loss with DCB as compared to standard PTA.There was a numerical but not
statistically significant increase in amputations with DCB therapy. The precise role
and method of delivery of anti-restenosis therapy BTK remains to be better defined.
5.6.3.1 Atherectomy
The increase in atherectomy use for the treatment of lower extremity PAD has been
profound over the past decade. The availability of choices of therapy from rota-
tional, orbital, directional, and laser has grown tremendously over this period of
time. There remains a paucity of data to suggest that one atherectomy device is
superior to another in terms of angiographic or clinical endpoints relevant to
CLI. Furthermore, the real-world role of atherectomy remains primarily as an
adjunctive tool for debulking or vessel modification in concert with PTA. The
growth in atherectomy use is likely multifactorial as these devices have allowed
interventionists to take on more complex disease which may have necessitated
bypass in the past and allowed improved angiographic results in calcified vessels. It
should also be noted that the favorable reimbursement for atherectomy in the United
States has no doubt added to the more widespread use and development of atherec-
tomy devices.
Given the lack of large adequately powered randomized studies, considerations
of atherectomy device selection should be made based on practical concerns.
Several commonly used BTK atherectomy tools are summarized in Table 5.6.
5.7 Complications ofBTK CTO Revascularization
As with treatment of any peripheral lesion, there are risks associated with each step
of therapy of BTK CTOs. Given that most cases are performed for limb salvage in
patients often with multi-organ dysfunction, major procedural complications can
significantly reduce the likelihood of wound healing and result in increased morbid-
ity and mortality. Specific complications which warrant discussion include distal
embolization and management of vessel perforation.
5.7.1 Distal Embolization
Distal embolization (DE) can take the form of subclinical or clinically relevant
events. A potential classification scheme is introduced in the table. Subclinical DE
occurs commonly during endovascular therapy and has been detected by Doppler
Table 5.6 Selected atherectomy devices with mode of action and key clinical data
Device Manufacturer Mode of action Key clinical data
CSI Cardiovascular Orbital atherectomy: diamond- The CONFIRM registry
Systems coated crown which rotates at demonstrated that in
Incorporated speeds varying from 60,000 to highly calcified lesions,
200,000rpm treatment with CSI
Ablates plaque to particle sizes atherectomy and
2m [37] adjunctive balloon
Sizing of crowns: angioplasty (PTA) was
Tibials/peroneal effective with a reduction
Reference vessel diameter: in stenosis from an
24mm average of 88% to about
1.25mm Solid Crown 10%, with a low
1.50mm Classic Crown percentage (5.1%) of
1.25mm Solid Micro Crown bail-out stenting due to
Below the ankle dissection [38]
Reference vessel diameter: The OASIS trial, which
24mm focused on infrapopliteal
1.25mm Solid Micro Crown lesions, demonstrated a
Micro crown 1.25mm size can low dissection rate (2.5%)
be used retrograde through 4 Fr with a CSI atherectomy +
precision (Terumo) sheath PTA strategy with a
Treats lesion in both directions 90.1% procedural success
Device used over a ViperWire rate [38]
(0.014 or 0.017 tipped)
Filter rarely needed, but NAV6
filter system (Abbott) can be
used off-label by back loading
on 0.017 tipped ViperWire
(CSI)
Jetstream Boston Rotational atherectomy device Multicenter Pathway
Scientific with or without blade PVD trial. Had 210
deployment for additional lesions (18 were BTK).
cutting TLR rates at 6months
Atherectomy is coupled with and 12months for BTK
active aspiration of debris lesions were 7.7% and
JETSTREAM XC (above the 15.4%, respectively [39]
knee) and SC (below the knee
[BTK], 1.6mm and 1.85mm
devices)
The SC devices do not have
expandable blades
Device used over a 0.014
JETWIRE.Off-label use over
filter wires has been performed.
Care should be taken when using
over Spiderwire (Medtronic) to
avoid vessel trauma or filter
damage from rotation of the filter
during atherectomy
Minimum sheath size is 7 Fr
(continued)
Table 5.6(continued)
Device Manufacturer Mode of action Key clinical data
Laser Spectranetics Excimer laser emits energy at a The LACI registry
wavelength of 308nm ablating examined the role of
thrombus and plaque adjunctive laser
Strengths are for crossing atherectomy to PTA or
un-crossable lesions stenting. A 92% limb
Most commonly used with salvage rate at 6months
adjunctive PTA was demonstrated [40]
Phoenix Volcano Front cutting system based on The EASE study was a
Corporation the Archimedes screw which prospective, multicenter,
captures and delivers plaque to a single-arm study of 105
waste bag patients (123 lesions).
56 Fr, 1.82.2mm catheter tip The majority of lesions
for BTK application were at or below the knee.
Reported technical
success of 95.1% (Results
presented at VIVA 2013)
Rotablator Boston Diamond tipped front cutting 150 patients with 212
Scientific burr delivered over a 0.009 burr lesions, 55% of the
Can be delivered through a 4 Fr lesions BTK [41]. 37
sheath or larger complications including
1.5, 1.75 or 2.0 burr sizes used perforation, dissection,
for BTK applications slow flow were reported.
Overall technical success
rate with adjuvant PTA
was 97%
TurboHawk/ Medtronic Directional cutting device with The DEFINITIVE LE
SilverHawk packing of plaque into nose cone study enrolled 800
Small vessel BTK cutters include patients with 18.5%
SS , SC, and EXL and ES lesions overall BTK in a
(24mm, 23mm diameter prospective multicenter
target vessels, respectively), 6 Fr trial [42]. The study
sheath compatible included 201 patients
Distal tibial and pedal cutter: DS with CLI (34.4% BTK
1.52.0, 5 Fr sheath compatible lesions). Procedural
success of 83% in the
CLI patients, with a 95%
freedom from amputation
at 12months
ultrasound studies which note high-intensity signals (HITS) during interventions.

Between subclinical and frank clinically relevant DE are more subtle angiographic
findings such as small vessel cutoffs or loss of side branches. These events may not
have immediate clinical impact or be amenable to further therapy; however their
longer-term impact on main vessel patency or limb salvage is unknown. Clinically
relevant DE, i.e., events which result in symptoms (pain, tissue loss) or result in
macrovascular flow impairment, appears to occur in 14% of cases [43]. When a
macro-embolus is visible, it may be retrieved using aspiration thrombectomy cath-
eters (see Fig. 5.15) [44, 45]. For more diffuse DE, use of a prolonged
a b
Fig. 5.15 Distal embolization of the anterior tibial artery. (a) Vessel cutoff, (b) after treatment
with manual aspiration thrombectomy
catheter-directed thrombolytic infusion may be helpful [46]. Adjuvant use of potent

antiplatelet therapy (glycoprotein 2b/3a receptor inhibitors) has been described [47].
Prevention of DE is a key consideration during BTK therapy. A classification
scheme for peripheral DE proposed by the author (Prasad) is demonstrated in Table
5.7. As noted earlier, BTK CTOs are often calcified and may contain thrombus. Tips
to avoid DE include use of aggressive vasodilators, limiting orbital or rotational
atherectomy run times, and maintaining adequate antithrombin and antiplatelet
therapy. EPDs, including filters, may be helpful at preventing macrovascular DE
and should be considered when the target vessel is appropriately sized. Use of distal
filters with orbital or specific rotational devices is considered off-label, and an
understanding of device-filter compatibility should be made prior to use. In our
practice, we have found it rarely necessary to use EPDs (Nav-6, Abbott Vascular)
with orbital atherectomy. Rather we follow the tips noted above. Given the avail-
ability of small size (34mm) Spider (Medtronic) filters, we often couple direc-
tional atherectomy with EPDs when vessel size will allow. Spasm around the filter
site can occur, but generally responds to intra-arterial nitroglycerin. Appropriate
sizing of the filter to 1.5 vessel diameter is helpful. Material within the filter can
embolize during retrieval, and we recommend a partial capture. This technique
entails closure of the filter aperture with the retrieval catheter but not complete inter-
nalization of the filter and potentially avoids cheese grating of material through
the pores. Lastly, EPDs can add significant cost to a case ($500$1000), and there
are a lack of randomized data. Decisions regarding use of these devices should be
made on a case by case basis (Table 5.7).
5.7.2 Perforation
Perforation is a serious complication which any CLI operator working in the tibial
region must be willing to recognize and treat immediately. The location of perfora-
tion within the tibial anatomy has important implications. Due to their location in
the calf, proximal tibial perforations are more serious and are likely to increase the
risk of compartment syndrome. The anterior compartment tends to be less forgiv-
ing, and bleeding into this space is more likely to result in symptoms. In addition,
given the depth of the vessel, perforation of the peroneal artery has to be addressed
more promptly regardless of the location along the vessel. There are several
options to manage extravasation once a perforation is recognized. First inflation of
an external blood pressure cuff to two thirds of systemic pressure around the calf
can be performed. The cuff inflation should be maintained for 35min intervals.
Table 5.7 Proposed classification of distal embolism events

Distal
embolization
type Manifestation Comments
Type I Subclinical embolic Unknown significance; commonly occurs during
high-intensity signals most endovascular procedures
(HITS) detected by
ultrasound
Type II Subclinical small distal Has little immediate clinical impact but
vessel cutoffs or loss of longer-term relevance is unknown
microvascular blush
Type III Clinical slow flow in Can be seen after atherectomy. Often responds to
macro-vessels without vasodilators (calcium channel blockers or
visible thrombus adenosine)
Type IV Clinical slow or no flow Macro-embolism can be related to thrombus or
in macro-vessels with atherosclerotic debris Can respond to aspiration
visible embolus thrombectomy, use of intravascular glycoprotein
2b/3a inhibitors, or thrombolysis
Type V Clinical no flow in May occur due to extensive microvascular
major vessel without congestion from diffuse embolization. May
visible embolus respond to vasodilators or thrombolysis.
Intravascular ultrasound may be helpful to
differentiate dissection from no-reflow
Second, inflation of an intravascular balloon to low atmospheric pressure to pre-

vent continued inflow should be considered. Again intervals should last anywhere
between 3 and 5min. The third option should be reserved for large perforations
and includes reversal of anticoagulation with protamine and consideration of more
aggressive endovascular therapies. Options include use of a covered stents and
branch or even main vessel coiling. Involving a surgeon for continued bleeding is
important as the concern for compartment syndrome is high in refractory cases.
5.8 Conclusions
For the majority of patients presenting with CLI, revascularization of BTK CTOs
remains the focus of successful limb salvage. Over the past decade, advances in
technology and techniques have allowed vascular specialists to treat more complex
disease including calcified and long occluded vessels. A careful approach to proce-
dural planning including comfort with retrograde approaches and complication
management is central to successful BTK CTO therapy.
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Chapter 6
Comparative Assessment ofCrossing
andReentry Devices inTreating Chronic Total
Occlusions forFemoropopliteal andBelow-
the-Knee Interventions
NicolasW.Shammas
Chronic total occlusions (CTOs) are widely prevalent in peripheral arterial interven-
tions. It is estimated that CTOs are encountered in 2550% of all lesions treated [1].
Multiple predictors of failure to cross CTO have been reported including lesion
length, the presence of side branches at the proximal or distal cap, heavily calcified
vessels, and operators experience. A failure rate of up to 50% has been reported
when intraluminal crossing of a CTO was attempted with conventional guidewires
[2, 3] but significantly improved with specialized crossing devices into the 70%
range [3]. A subintimal approach is likely to have a higher initial success rate in the
80% range, but this is dependent on operators familiarity with reentry devices and
lack of severe calcification at the reentry site. Also a higher loss of patency is seen
with an initial subintimal approach on intermediate-term follow-up [46]. In all
comers, the overall technical failure rate remains high at approximately 20% with
conventional guidewires and balloons [2, 7]. In this chapter we review published
data on CTO devices in peripheral interventions. Randomized comparisons of the
effectiveness and safety of these devices in treating CTO are lacking. We therefore
present observational studies and non-randomized comparisons between these
devices while acknowledging the significant limitations of the data.
Recent advances in crossing CTO have allowed endovascular specialists to treat
these lesions percutaneously rather than by primary surgical bypass. National trends
in treating lower extremity peripheral arterial disease indicate that between 2001 and
2007, endovascular interventions increased by 78% and surgical bypasses reduced
by 20%. During the same period, total amputations (59,693 vs 50,254, p < 0.001),
major amputations (39,543 vs 31,043, p < 0.001), and minor amputations (20,150 vs
19,211, p < 0.001) were all significantly decreased [8]. Percutaneous intervention is
N.W. Shammas, MD, MS, FACC, FSCAI

Midwest Cardiovascular Research Foundation, 1622 E Lombard Street, Davenport,
52803 Iowa, USA
Cardiovascular Medicine, PC, Davenport, Iowa, USA
e-mail: Shammas@mchsi.com

Total Occlusions, DOI10.1007/978-981-10-3053-6_6
76 N.W. Shammas
likely to be associated with quicker recovery, shorter length of hospital stay, and less
acute complications.
Multiple catheters are available for treating CTO. The Crosser (Bard) and
TruePath (Boston Scientific) are devices designed for intraluminal crossing. The
rotational energy at the tip of the devices is transmitted to the CTO cap where intra-
luminal recanalization is achieved in 75% and 80%, respectively [9, 10]. Also, the
Cordis Frontrunner XP (Cordis Corp.) uses microdissections as it enters the
plaque, whereas the Viance (Medtronic) relies on a fast spin of its atraumatic tip
for crossing. The Wildcat (Avinger, Inc.) uses spiral wedges on the tip of the
catheter that corkscrew the CTO.Finally, the Ocelot (Avinger, Inc.) uses optical
coherence tomography (OCT) to visualize the lumen as it crosses the occlusion.
6.1 Definitions
In order to meaningfully compare between devices and strategies, it is important to

have standardized definitions to what constitutes technical success and procedural
success in treating CTO [3]. Technical success is defined as the placement of a
guidewire in the distal true lumen past the distal CTO cap confirmed by either angi-
ography or intravascular ultrasound. Technical success can be primary, secondary,
or provisional. Primary success is a successful crossing with the initial crossing
strategy, whereas secondary success is a failure to cross with the initial strategy but
achieving success with the use of an alternate crossing device. Provisional success
is subintimal passage with the initial crossing strategy with subsequent successful
intraluminal crossing with reentry device. Finally, procedural success is obtaining
less than or equal 30% residual narrowing at the end of the treatment of a CTO.
6.2 P
rimary Crossing Devices VersusPrimary Wire-
Catheter asInitial Crossing Strategy
Data from the Excellence in Peripheral Arterial Disease (XLPAD) registry [3] have
demonstrated that an initial strategy with the use of a crossing device leads to a higher
chance of crossing success when compared to the use of guidewires and catheters.
Four-hundred and thirty-eight CTO lesions were analyzed from the XLPAD registry.
Two-hundred and ninety-five (67.4%) lesions were treated with primary wire-cathe-
ter and 143 (32.6%) with primary CTO crossing device. Switching to a CTO crossing
device and use of reentry device were more frequent in the wire-catheter versus the
crossing device strategy (28.1% vs 4.9% and 26.7% vs 17.5%, respectively). Primary
technical success was higher in the CTO device versus wire-catheter strategy (72.1%
vs 51.9%, respectively, p<0.001), but secondary technical success (71.4% vs 67.5%,
p=1.0), provisional technical success (87.5% vs 84.2%, p=0.768), and procedural
success (90.9% vs 93.6%, respectively, p = 0.332) were similar between the two
groups, respectively. In addition, the use of CTO devices was associated with longer
6 Comparative Assessment ofCrossing andReentry Devices inTreating Chronic 77
procedural times, more contrast use, and longer fluoroscopy times. Furthermore,
30-day and 1-year outcomes were similar between both groups, but there was a sig-
nificantly higher surgical revascularization rate in the primary wire-catheter arm
(8.8% vs 2.8%, p=0.025). Finally, the improvement in the Rutherford-Becker cate-
gory and ankle brachial index (ABI) was also similar between the two groups when
compared to baseline. Viance and Frontrunner devices were the predominant
crossing devices used in this registry (84%). The Viance catheter was mainly used
in below-the-knee and popliteal lesions, whereas the Frontrunner was used more in
the superficial femoral artery lesions (100% vs 64.5%, p<0.0001). This data is lim-
ited by its retrospective nature with a likely selection bias to the choice of the crossing
device. Also the influence of operators experience was not taken into account as well
as cost-effectiveness of various crossing strategies.
A primary wire strategy followed by a reentry device as bailout has also been
shown to be effective in achieving a high technical success in treating a CTO.In a
retrospective analysis from Germany, 128 patients with 146 lesions were treated
with a wire-only strategy first followed by a reentry strategy in 7 out of 13 lesions
that were not successfully crossed. A high technical success was accomplished with
a wire-only strategy at 91.9%. When a reentry device was used, technical success
was achieved in 100% of cases. The authors concluded that technical success can be
achieved in more than 90% of all cases with CTO of the lower extremity using a
wire-only strategy, and when a reentry device is used after failure of wire crossing,
a technical success rate of 100% can be achieved [11].
It can be concluded that a primary technical success is likely to occur with the
initial use of specialized crossing devices instead of conventional guidewires.
However, a high secondary technical success is seen when switching to an alternate
strategy. This indicates that it may be more cost-effective to use specialized crossing
or reentry devices after failure of conventional guidewires. This will likely result in
high rates of crossing the CTO and overall procedural success. Table 6.1 summa-
rizes data from several small studies describing technical and procedural success
and the use of fluoroscopy and contrast dye with various crossing or reentry devices.
6.3 Crossing Devices (Table 6.1)
6.3.1 TruePath (Boston Scientific)
The TruePath system (Fig. 6.1) creates microdissection in CTOs to facilitate

access into hard and calcified caps. It is a 0.018 guidewire compatible. The tip (Fig.
6.2) is diamond coated and rotates at 13,000rpm. It has audible and visual alerts
that are activated when excessive resistance is encountered. The tip may be bent up
to 15 to help steering it in different directions.
In a small series from the XLPAD registry, 13 patients with mostly TASC C and D
lesions and femoropopliteal (FP) CTO were treated with the TruePath device after
an unsuccessful guidewire crossing attempt. Twelve lesions were de novo and severely
calcified. Technical success was 77%. In three patients, subintimal recanalization
78
Table 6.1 Published literature on intraluminal crossing devices

LL De novo Primary Reentry Stent Fluro Contrast
Devices n (mm) (%) Calcium (%) Location (%) TS (%) TS (%) use (%) PS (%) (%) (min) (cc) References
TruePath 13 169.8 92.3 Severe=92.3 SFA 77 100 77 23 100 61.5 41 200 [12]
(<30%)
TruePath 85 * * Moderate or SFA 71.8 80 * * * * * * [14]
severe=85
Crosser 73 * 95.9 Moderate or * 87.7 76.7 13.7 * 51.6 * * [15]
severe=57.6
Crosser 85 117.5 * Moderate or SFA 61.2, pop 83.5 * * 75.3 51.8 39.1 242 [16]
severe=75 20, IP 16.5 (<50%)
Viance# 37 81 97 Severe=41 Pop and IP 70 65 4 5 28 189 [39]
100
Viance 58 140 93.1 Severe=93.1 SFA 58.6 96.6 87.9 12.1 85.7 51.7 39.1 187 [13]
Frontrunner 26 176 * Heavy=68 FemPop 100 65.38 * 9 * * 22.9 * [17]
XP
Frontrunner 22 180 100 Mild=86.4, FemPop 100 95.5 95.5 * 95.5 * * * [18]
XP Severe=9.1
Wildcat 84 174 88.6 Moderate=57; SFA 85.2 89 75 17.8 89.8 34.1 30.2 247 [19]
Severe=1.2 (<50%)
Ocelot 100 16.6 89 Moderate=36 SFA 94, Pop 4, 97 72 * 97 * 38.6 223 [20]
FP 2
Ocelot 33 205 94 Severe=21, SFA 100 100 83.9 16 * 71 28 132 [21]
Moderate=12
# Viance and CrossBoss, * missing info, SFA superficial femoral artery, Pop popliteal, IP infrapopliteal, Fempop femoropopliteal, cc ml, TS technical success,
PS procedural success, min minute, Fluro fluoroscopy, LL lesion length, Reentry use reentry device use, n number
N.W. Shammas
Fig. 6.1TruePath
system ( 2015 Boston
Scientific. Image(s) used
with permission)
Fig. 6.2 TruePath tip is

diamond coated and rotates
at 13,000rpm ( 2015
Boston Scientific. Image(s)
used with permission)
occurred requiring the use of reentry device. Sixty-two percent of patients were stented,
and average fluoroscopy time was 41.1min and contrast use 200mL [12]. Also Bosiers
etal. [14] reported results of the ReOpen trial in which 85 CTO lesions were treated
with the TruePath device. Moderate or severe calcifications were present in 85% of
lesions. Technical success was achieved in 80%. Figure 6.3 illustrates CTO crossed
successfully with TruePath with establishing intraluminal wire position.
6.3.2 Viance (Medtronic)
The Viance catheter (Fig. 6.4) has a 2.3 Fr shaft made of coiled multiwire and a 3
Fr rounded atraumatic tip. It is an over the wire and is 0.014 guidewire compatible.
The tip is advanced to the proximal CTO cap and manually spun using a torqueable
80 N.W. Shammas
a b
c d
Fig. 6.3 Chronic total occlusion (a) could not be crossed with angled-tip extra-stiff glide wire
(deflecting into a side branch), (b) was engaged successfully with TruePath (c) (Boston
Scientific), and intraluminally successfully crossed (d)
handle (Fig. 6.5). Using a fast spin technique and forward pushability, the Viance
tip passes through the CTO via the true lumen or subintimally. The Viance has an
angulated tip that helps navigating staying away from a side branch at the caps. Also
as the device is advanced forward, the wire is retracted proximal to the tip.
Fig. 6.4 Viance catheter

( 2015 Medtronic.
Image(s) used with
permission)
Fig. 6.5 Viance torqueable handle ( 2015 Medtronic. Image(s) used with permission)
Fifty-eight patients from the Excellence in Peripheral Artery Disease (XLPAD)

registry were treated with the Viance catheter; mean lesion length was 140.0mm;
93.1% of lesions were de novo, and 81.0% were severely calcified [12]. Primary
technical success was 87.9% of cases, and procedural success was 85.7%. It should
be noted that the technical success was significantly less with the Viance after an
unsuccessful attempt by the guidewire (50%) when compared to 95.8% after an
initial Viance crossing attempt. The Viance entered the subintimal space in
12.1% of cases, and a reentry device was used. Reentry device success was 71.4%.
Additional data from the same registry with application exclusively to below-the-
knee CTO achieved primary technical success in 65% of lesions treated. In this
registry, 37 lesions were treated with the Viance or the CrossBoss catheters;
mean lesion length was 81mm, and 41% of lesions are severely calcified. Subintimal
entry was achieved in 14% of lesions. Procedural success was achieved in 85.7% of
lesions successfully crossed. The main predictor of procedural failure was long
lesion length with mean length of 136mm.
6.3.3 Frontrunner XP (FR-XP) (Cordis)
The FR-XP catheter has no guidewire lumen. It consists of a proximal braided shaft
to assist in pushability and torque and a flexible distal shaft that can be manually
shaped. The radiopaque distal actuating tip is made of a set of bilateral hinged pieces.
The device creates a blunt microdissection through a CTO which enables intralumi-
nal guidewire entry. A micro-guide catheter is recommended for use with the FR-XP
to provide additional support to the distal portion of the crossing device and also to
facilitate guidewire placement into the CTO. The FR-XP is placed through the
82 N.W. Shammas
Fig. 6.6Frontrunner
creating a larger
microdissection plane into
the chronic total occlusion
(2015 Cordis, Image(s)
used with permission)
proximal cap of the CTO with jaws closed and then repeatedly pulled back with an
open jaw. This allows a larger microdissection plane into the CTO (Fig. 6.6).
Charalambous etal. [17] treated 26 SFA CTO with the Frontrunner catheter
following failure of conventional guidewire crossing. Severe calcification was pres-
ent in 68% of the lesions, and the mean lesion length was 17.6cm. Technical suc-
cess was 65.4%. Predictors of failure were severe calcification and inability to
reenter the lumen after successful subintimal passage [13, 17]. The mean fluoros-
copy time was 22.9min. Also Shetty etal. [18] treated 22 patients with femoropop-
liteal CTO (mean occlusion length, 18.0 10.1 cm) with the Frontrunner XP
catheter after guidewire failure. Technical success was 95.5%.
6.4 Crosser Catheter System (Bard)
The Crosser CTO Recanalization System is comprised of an electronic generator,

foot switch, high-frequency transducer, the FlowMate Injector, and Crosser cath-
eter. It is both 0.014 and 0.018 guidewire compatible. The tip is metal (either stain-
less steel or titanium) and uses high energy vibration to penetrate hard caps. The
guidewire is advanced to the site of the occlusion. The Crosser catheter (Fig. 6.7) is
then passed over the guidewire until it reaches the occlusion (Fig. 6.7a). Following
pulling back the guidewire, the device is activated and slowly advanced into the lesion.
Staniloae etal. [15] reported on 56 subjects with 73 CTOs who were treated with
the Crosser device. Primary technical success was 76.7%. Secondary technical
success was 87.7%. A higher technical success was seen in CTOs in the aortoiliac
(90.0%) and tibial (95.2%) vessels. The mean time to cross the CTO was 17.6min.
a b
Fig. 6.7(a) Crosser CTO catheter ( 2015 C.R. Bard, Inc. Image(s) used with permission). (b)
Crosser CTO catheter engaging total occlusion ( 2015 C. R. Bard, Inc. Image(s) used with
permission)
Fig. 6.8 Wildcat with a rotatable tip that can assume both passive (wedges in, a) and active
(wedges out, b) configurations ( 2015 Avinger, Inc. Image(s) used with permission)
No perforations were reported. Longer lesions (>100mm) and c alcification within

10mm of the exit cap were predictors of failure to cross. More recently, Laird etal.
[16] reported the results of the PATRIOT trial. In this study, 85 patients with failure
to cross a CTO with conventional guidewires were treated with the Crosser device.
Vessels treated included the superficial femoral artery in 61.2%, popliteal artery
20%, and tibioperoneal arteries in 16.5%. Mean occlusion length was 117.5mm
with 75% were moderately to severely calcified. Technical success was 83.5% with
zero Crosser catheter-related perforations. Procedural success was 75.3% (50%
residual stenosis). Average Crosser catheter activation time was 2min and 6s.
6.4.1 Wildcat (Avinger)
The Wildcat has a rotatable tip that can assume both passive (wedges in) and
active (wedges out) configurations (Fig. 6.8a, b). The passive mode is the recom-
mended initial mode. For fibrocalcific lesions, the active mode is used. Recently, a
handheld motorized unit can be used to rotate the device. The 0.014 versions of
this device (Kittycat and Kittycat 2) may allow better crossability of smaller vessels
for both above-the-knee or tibial lesions.
84 N.W. Shammas
In a multicenter study at 15US sites, 84 patients with CTO were treated with the
Wildcat crossing catheter per protocol after an initial failure attempt using con-
ventional guidewires. Technical success was 89% (n=75). Primary technical suc-
cess was 75%. Five percent of cases had major adverse events (minor perforations
sealed with balloon angioplasty). Of the 75 patients successfully crossed, 17.8%
required the use of a reentry device which was successful in 80%. Procedural suc-
cess was 89.8% [19].
6.4.2 Ocelot (Avinger)
The Ocelot CTO crossing device (Fig. 6.9a) is an over-the-wire device with opti-
cal coherence tomography (OCT) imaging capability and consists of a catheter shaft
with crossing distal tip and a proximal handle assembly. OCTs infrared spectrum is
reliable in identifying plaque morphology [22, 23] and provides continuous A-scans
that are translated into extrapolated images that guide navigating the tip within the
CTO.The OCT image generated by the Ocelot catheter is related to the devices
orientation (Fig. 6.9b). The distal tip of the catheter consists of spiral flutes and a
fiber optic used in conjunction with a light box to help in directing the intravascular
tip position using directional markers. The latter remains stationary in the OCT
display unless the outer shaft of the catheter is rotated. The device is not intended
for use in the coronary, iliac, renal, carotid, or cerebral vessels.
b NON-LAYERED STRUCTURES
Indicated intravascular
deseased tissue
MIDDLE MARKER
To work in a synchronized
environment
LAYERED STRUCTURES
Indicated intravascular
arterial structures
Fig. 6.9(a) Ocelot CTO crossing device ( 2015 Avinger, Inc. Image(s) used with permission).
(b) The OCT image generated by the Ocelot catheter is related to the devices orientation (
2015 Avinger, Inc. Image(s) used with permission)
In the CONNECT II study, a prospective, multicenter, nonrandomized single-

arm study evaluating the safety and effectiveness of the Ocelot catheter in CTO
crossing that could not be crossed with a guidewire, 100 patients (94% superficial
femoral artery, mean lesion length 16.6mm) were included. The primary technical
success was 72%, and the overall technical success was 97%. A reentry device was
used in 7% of patients [20]. Also Schwindt et al. [21] reported their data on 33
patients with SFA CTO crossed with the Ocelot catheter. Technical success was
100% despite mean lesion length of 205mm. Primary technical success was 83.9%.
Reentry device was used in 16% of cases, and stent rate was 71%.
When the Ocelot was compared to the Wildcat using data from CONNECT
[19], a significant reduction in procedure time and contrast use were obtained with
the OCT-guided Ocelot catheter. There was, however, no significant difference in
the rate of perforations, embolizations, or dissections. Although numerically the
Ocelot had a better ability to cross the CTO than the Wildcat (100% vs 95.2%),
this was not statistically significant. When a select cohort of Ocelot patients who
met the inclusion and exclusion criteria of the CONNECT study were separately
analyzed, the CTO was successfully crossed in 100% of the time.
6.5 Reentry Devices (Table 6.2)
6.5.1 Subintimal Angioplasty ofCTO Lesions
Subintimal angioplasty (SIA) is an effective, low-cost, and easy-to-learn method in

treating femoropopliteal CTO.The immediate- and short-term results are encourag-
ing. In addition to improving claudication, limb salvage has been demonstrated in
Table 6.2 Published literature on reentry devices

De
LL novo TS Procedural Stent Fluro
Devices n (mm) (%) Location (%) (%) success (%) (%) (min) References
Outback 52 176 100 SFA 90.4, 64.5 * * * [24]
LTD SFA/pop 9.6
Outback 51 230 100 Iliac15.7, FP 96.1 96.1 96.1 * [25]
82.3
Outback 65
200 100 SFA 100 88 88 * * [26]
Outback 26
* 100 * 100 * * 29.8 [27]
Pioneer 25
127 100 SFA 100 100 100 (<25%) 100 * [28]
Pioneer 21
iliacs 100 Iliac 18, SFA 100 * 100 38 [1]
8.5, 3
SFA 1.5
OffRoad 92 175.1 100 SFA/Pop 84.8 * * 21 [29]
Enteer 21 * * * 86 * * * Unpublished#
n number, LL lesion length, mm millimeter, TS technical success, Fluro fluoroscopy, min minute,
SFA superficial femoral artery, Pop popliteal, FP femoropopliteal, # from Boston Sci. web page,
* data not available
86 N.W. Shammas
limb ischemia patient. Unfortunately, SIA is associated with a low patency rate at
1 year ranging from 45% to 62% [3033]. Predictors of loss of patency in SIA
include long lesions, limb ischemia, and diabetics. Furthermore, a subintimal
approach is associated with a high rate of dissection and stenting. Finally, a subinti-
mal approach nearly eliminates the possibility of atherectomy as a first-line treat-
ment. Although some reports indicated that SIA may reduce distal embolization
[34], this has not been demonstrated consistently in all studies [35, 36]. This
approach, in our laboratory, is limited only to patients in whom an intraluminal
approach is demonstrated to be difficult to accomplish successfully. The main rea-
son for SIA failure is reentry into the true lumen, generally hindered by severe cal-
cification at the reentry site or lack of experience of the operator with the device
being used. Below is a list of reentry devices that are currently available.
6.5.2 Pioneer (Medtronic)
The Pioneer catheter is 0.014 wire compatible catheter with a solid-state intravas-
cular ultrasound (IVUS) transducer (Volcano Therapeutics) and a hypo-tube through
the lumen with a curved retractable nitinol needle (Fig. 6.10). After subintimal entry
and reaching the desired true lumen entry point, the catheter is rotated so the true
lumen is at 12 oclock on the IVUS image. The curved needle tip is then advanced
Fig. 6.10Pioneer
catheter with a curved
retractable nitinol needle
Fig. 6.11 Pioneer retractable needle is retracted and wire crossed intraluminally
away from the IVUS catheter into the true lumen. An exchange length extra-support
0.014 guidewire is then passed from the needle into the true lumen. The needle is
retracted, Pioneer catheter withdrawn, and intervention continued (Fig. 6.11).
Jacobs etal. [1] reported on the use of a true lumen reentry device in 24 femoral
and iliac CTOs using predominantly the Pioneer catheter in 21/24 (87.5%). All 21
vessels treated with the Pioneer catheter (18 iliac and 3 SFA) could not be suc-
cessfully crossed initially by standard catheter, and wire techniques were crossed
successfully at a mean of 38min. No bleeding occurred at the site of true lumen
entry. All patients had to be stented. Technical success was 100%. Also, Scheinert
et al. [28] reported on 25 consecutive patients with failed attempt to recanalize
chronic superficial artery occlusion (mean occlusion length 12.7cm) with standard
techniques and were rescheduled for a secondary recanalization procedure.
Technical success was achieved in 100% of cases. Predilatation of the false channel
was performed in eight cases with severe calcification to allow advancement of the
Pioneer catheter. All patients were stented, and procedural success was 100%.
6.5.3 Outback (Cordis)
The Outback catheter (Fig. 6.12) uses a retractable curved nitinol needle positioned
under fluoroscopy in two different orthogonal views toward the true lumen. After cross-
ing the subintimal space with a crossing catheter and 0.035 hydrophilic wire, the 0.035
88 N.W. Shammas
Fig. 6.12 Outback catheter (2015 Cordis. Image(s) used with permission)
wire is then exchanged for a 0.014 non-hydrophilic support wire (we typically use the
Spartacore wire from Abbott). The Outback catheter was then placed over the 0.014
and advanced under fluoroscopy to the desired reentry site. The L radiopaque marker on
the catheter is initially oriented toward the lumen (Fig. 6.13). After rotating the image
intensifier 90 orthogonally, the radiopaque marker is simultaneously oriented to form a
T over the center of the lumen (Fig. 6.13b). The needle is then deployed, guidewire
advanced through the needle, and then needle retracted, followed by removal of the
Outback catheter while keeping the guidewire into the true lumen (Fig. 6.14).
In a study by Shin et al. [24], 52 lesions were treated with the Outback LTD
reentry device (47 SFA and 5 combined SFA/popliteal). Reentry was successful in
64.5% of cases. The main predictor of failure included the presence of moderate or
severe calcification at site of reentry. In general failures were related to inability to
reenter the lumen (61.1%), acute aortic bifurcation angle (11.1%), device failure
(5.6%), and difficulty tracking the device over the wire (16.7%) or the device though
the lesion (5.6%). Also Beschorner et al. [26] reported 88% success rate in the
recanalization of 65 superficial femoral artery CTOs using the Outback reentry
catheter after failure of crossing using conventional guidewires. Lesion length was
200mm. In addition, Aslam etal. [25] reported a procedural success of 96.1% in
crossing 51 CTOs of iliofemoral and femoropopliteal lesions (mean lesion length
a b
Fig. 6.13(a) The L radiopaque marker on the Outback catheter oriented toward the lumen.
Arrow point to the L marker directed toward lumen (b) The radiopaque marker on the Outback
catheter is simultaneously oriented to form a T over the center of the lumen. Arrow points to
the T marker over the vessel
230mm) using the Outback LTD catheter. Furthermore, in a small randomized trial
by Gandini etal. [27], true lumen reentry was attempted in 52 superficial femoral
artery CTO, 26 with conventional guidewires, and 26 with the Outback LTD cath-
eter. Technical success was achieved in 100% of cases. The conventional wire group
achieved planned in-target reentry in 42.3%, whereas the Outback group 88.4%.
The mean procedural time in the conventional wire group was 55.4 14.2min with
a mean fluoroscopy time 39.6 13.9min compared to 36.0 9.4min and 29.8
8.9min, respectively, in the Outback group. The authors concluded that the use of
the Outback reentry was associated with high technical success rates and a signifi-
cant reduction of procedural and fluoroscopy times.
Recently, Kitrou etal. [37] published their data on 91 patients (100 vessels) with
the Outback catheter. All vessels failed initial spontaneous reentry. Fifty-two vessels
were iliac occlusion, and 48 were infrainguinal. The Outback was successful in
reentry in 93% of cases, and failure to reenter the true lumen was due to severe
calcification at the reentry site. There were no major complications reported. A sys-
tematic review by the authors on published literature on the Outback catheter noted
a successful reentry in 90% of cases with an overall complication rate of 4.3%. The
authors concluded that the Outback has a high success rate in reentering the true
lumen with low complication rates.
90 N.W. Shammas
Fig. 6.14 Outback catheter removed while keeping the guidewire into the true lumen. Arrows
point to the wire after crossing into the true lumen
6.5.4 Enteer (Medtronic)
The Enteer Re-entry system (Fig. 6.15) has two components: an orienting balloon
catheter and a reentry guidewire. The balloon catheter is indicated for directing,
steering, controlling, and supporting the guidewire. It has a 150-cm shaft length
and is 0.018 wire compatible. The balloon is flat shape and designed to self-orient
one of two 180 offset exit ports toward the true lumen. Enteer can be used for
above- and below-the-knee applications. Under fluoroscopic guidance, the balloon
is advanced to the planned reentry site. The guidewire is then exchanged with a
barbed reentry, angled-tip guidewire with different level of stiffness designed to
enter the true lumen from the exit port of the balloon located in the subintimal space.
Once true lumen access is accomplished, the reentry balloon is removed, and the
barbed wire is exchanged with another guidewire followed by intervention.
In the multicenter (9 US sites) Peripheral Facilitated Antegrade Steering
Technique in Chronic Total Occlusions (PFAST) CTO pivotal study, 66 patients
with infrainguinal arteries (mean CTO lesion length 19.5 10.8cm) were included.
In 45 cases, the BigBoss (Viance) was used alone, and in 21 cases, reentry was
Fig. 6.15 Enteer Re-entry system ( 2015 Boston Scientific. Image(s) used with permission)
Fig. 6.16OffRoad
Re-entry system (
2015 Boston Scientific.
Image(s) used with
permission)
attempted using the Enteer Re-entry system. Overall technical success was 86%
(18/21) with the Enteer system. The data of this trial has not been published yet [38].
6.6 OffRoad (Boston Scientific)
The OffRoad Re-entry system (Fig. 6.16) is a dual-component system with a 70cm
over-the-wire 0.035 compatible catheter system, the tip of which has a 5.4 mm
conical-shaped positioning balloon and a flexible neck that allows directing the bal-
loon toward the true lumen and a hollow 0.014 compatible micro-catheter Lancet
with a hydrophilic coating and a lancet tip. The lancet tip is designed to facilitate
reentry into the true lumen (Fig. 6.17). The system can be used with a 6F sheath.
After guidewire reaches the desired reentry location, it is removed and replaced by
the Lancet micro-catheter. The balloon is then inflated at nominal pressure of two
atmospheres (maximum 3.25 ATM) which redirects the balloon toward the true
lumen. The Lancet is then advanced into the true lumen followed by advancing the
0.014 guidewire. The Lancet is retracted and removed, balloon deflated and cath-
eter removed, and intervention continued.
92 N.W. Shammas
Fig. 6.17OffRoad
lancet tip designed to
facilitate reentry into the
true lumen ( 2015 Boston
Scientific. Image(s) used
with permission)
Schmidt etal. [29] reported data on the OffRoad Re-entry Catheter System in the
femoropopliteal arteries. This single-arm, prospective study of 92 patients with
CTO of the femoropopliteal artery was conducted at 12 European centers; technical
success was 84.8%. Major adverse events including death, perforation requiring
intervention, clinically significant peripheral embolism, and major amputation of
the treated lower limb at 30days were 3.3%.
6.7 Conclusion
Several strategies and devices are now available to the endovascular specialist to
treat CTO of infrainguinal arteries. The best strategy is yet to be defined. An initial
attempt with a specialized crossing device yields a higher primary technical success
than the use of a conventional guidewire; however, after failure of the initial strat-
egy, a second attempt with an alternate strategy seems to yield similar technical
success. Provisional technical success with reentry device or a primary subintimal
technique is also high, but subintimal intervention carries an overall low patency
rate on follow-up, requires a high rate of stenting, and nearly eliminates the use of
atherectomy as a primary modality for treatment. Current crossing or reentry devices
all enhance technical success. Operators experience is critical for optimal perfor-
mance. We recommend that an operator gets familiar with one or two of the crossing
and reentry devices and use them frequently enough to build and sustain a high-
level experience in crossing CTO.
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Chapter 7
Complications ofPeripheral Arterial
Interventions
MazenAbu-Fadel
7.1 Introduction
Atherosclerotic disease remains the most common cause of death in the Western
world. Data from population studies have demonstrated an increased prevalence of
peripheral arterial disease (PAD) in patients older than 40years of age. In the cur-
rent era of advanced endovascular equipment, techniques and expertise in PAD
interventions, percutaneous interventions on aortoiliac, and femoropopliteal and
infrapopliteal disease have increased significantly with very favorable outcomes
compared to surgical revascularization. Complications from such procedures can be
both life and limb threatening. Timely diagnosis and managment of complications
is crutial to prevent unfavorable outcomes. This chapter sumarizes the complica-
tions most likely seen in peripheral arterial interventions and discusses dianostic
and theraputic approaches to treat them.
In patients undergoing endovascular therapy for symptomatic PAD, 60% of dia-
betics and 30% of nondiabetics will have a chronic total occlusion (CTO) of at least
one arterial bed of the lower extremities [1]. It has become evident that endovascu-
lar management of femoropopliteal lesions even CTOs results in good primary and
secondary patency at 2 years. This therapy should be considered as first-line option
for many patients with peripheral artery disease, including those with critical limb
ischemia, claudication with poor bypass conduit, or patients at high medical risk for
open surgical revascularization [2]. Such percutaneous approaches have become the
treatment of choice for the majority of patients presenting with atherosclerotic
PAD.Complications of endovascular procedures, although infrequent, can occur in
M. Abu-Fadel, MD, FACC, FSCAI

Associate Professor of Medicine, Vice Chief, Section of Cardiovascular Medicine Director,
Interventional Cardiology & Cardiac Cath Lab Program Director, Interventional Cardiology
Fellowship University of Oklahoma HScC, Oklahoma City, OK, USA
e-mail: mazen-abufadel@ouhsc.edu

96 M. Abu-Fadel
as many as 58% of endovascular procedures and may result in significant disability

including limb loss and death. This chapter will review the most commonly encoun-
tered complications including access site complications, perforations/ruptures, dis-
sections, and distal embolization.
7.2 Arterial Access forEndovascular Interventions
Access site complications remain the most encountered complication of any diag-
nostic or interventional procedure. Such complications were much more frequent in
the early years of endovascular interventions due to the need for larger introducer
sheaths (910F). More recently, improved technology and specialized equipment
have allowed the interventionalist to perform more complex procedures through
smaller sheaths and alternate access routes such as radial, brachial, popliteal, and
pedal arteries. However, the common femoral artery (CFA) remains the most com-
monly used artery for endovascular interventions. Multiple factors increase the risk
of complications after vascular access. These factors are divided into modifiable or
non-modifiable risk factors or, more commonly, into patient- or procedure-related
factors. Patient-related factors include patients sex, age, body mass index, compli-
ance with bed rest, and the presence of chronic diseases such as hypertension and
renal dysfunction. Procedure-related factors include operator experience, faulty
access technique including venous punctures or multiple arterial punctures, subop-
timal arteriotomy site, sheath size, sheath dwell time, and periprocedural medica-
tions including thrombolytic, anticoagulation, and antiplatelet agents.
The first and most important step in avoiding access site complications is to use
meticulous technique to obtain access into the arterial circulation. Ideally, the CFA
should be accessed below the most inferior border of the inferior epigastric artery
(IEA) and above the CFA bifurcation into the profunda and superficial femoral
arteries (Fig. 7.1). In 35% of patients, the bifurcation of the CFA occurs below the
inferior border of the femoral head [3]. This segment of the CFA from the inferior
border of the femoral head to the bifurcation should also be avoided since this part
of the CFA cannot be easily compressed against the head of the femur to achieve
hemostasis. Access below the CFA bifurcation or the inferior border of the femoral
head whichever of these landmarks is more cranial will result in an increased
risk of hematomas and pseudoaneurysms. On the other hand, access above the most
inferior border of the (IEA) will increase the risk of retroperitoneal hemorrhage
which may be fatal [4]. In light of these considerations, the ideal access site into the
CFA lies at or just above the middle of the head of the femur (Fig. 7.1) [5]. If a
previous angiogram of the access site is available, it is very important to review it
prior to attempting access into the same CFA to determine the location of the infe-
rior epigastric artery and bifurcation into profunda and SFA arteries to ideal the
optimal site for atrial access. If this is not available, appropriate techniques should
be used to ensure an ideal puncture site into the CFA.
Fig. 7.1 Access site

angiogram showing the
ideal arteriotomy site over
the midline of the femoral
head (star). The
lowermost deflection of
the inferior epigastric
artery (IEA) is shown
(white arrow) as well as
the common femoral
artery bifurcation (black
arrow)
Fluoroscopy guidance may help in improving access into the CFA.In general,
fluoroscopy may be used in two different ways. The first is the indirect fluoroscopy
technique where a metallic object such as the tip of a hemostat can be used to locate
the inferior border of the femoral head under fluoroscopy in the posterior-anterior
projection with no cranial or caudal angulation. Access to the CFA can then be
achieved by advancing the needle from that landmark toward the CFA.It has been
shown that this technique does not increase the success rate of cannulating the CFA
but it does significantly decrease arteriotomies below the most inferior border of the
head of the femur [3]. The reason why indirect fluoroscopy is not always helpful has
to do with the fact that the amount of subcutaneous tissue that the needle has to
traverse before entering the CFA is variable from patient to another and thus the
arteriotomy site will be variable. In addition, this technique will not help locate the
CFA bifurcation prior to sheath insertion.
98 M. Abu-Fadel
On the other hand, the direct fluoroscopy technique requires repetitive fluoros-
copy of the access site with low-dose fluoro in the posterior-anterior projection with
every needle advancement until access is established at the desired level. This tech-
nique is best done with a micropuncture needle. After locating the inferior border of
the femoral head, repeat fluoroscopy is performed after the needle has been advanced
into the subcutaneous tissue but has not entered the CFA.This will help the operator
guide the tip of the needle toward the middle of the femoral head to achieve an ideal
puncture site. This method will increase the radiation exposure to the patient and to
a certain extent to the operator. It is crucial to keep fluoroscopy use to a minimum.
In addition, the bifurcation of the CFA is also not identified prior to access and
imaging of the site with angiography [6]. When using a micropuncture needle, the
operator should follow the wire into the iliac circulation and the distal aorta under
fluoroscopy since the 0.018 wire may travel into small branches (Fig. 7.2) and
cause a wire perforation that may lead to retroperitoneal hemorrhage [7]. Prior to
inserting the procedural sheath, a femoral angiogram should be done using the
micropuncture sheath dilator. It is best to do the angiogram by attaching the sheath
dilator to a pressure transducer prior to injecting through it to make sure it is in the
true lumen and not against the vessel wall to avoid dissections and perforations.
After angiography, if the access site is not in an ideal location, the dilator can be
removed and manual pressure held for 35min and access reattempted now that
there is a femoral angiogram to guide access into the CFA.It is important to men-
tion that injecting through the micropuncture dilator has a risk of iliac artery dissec-
tion especially in tortuous arteries.
Without a previous angiogram for CFA access, fluoroscopy cannot always iden-
tify the optimal access site due to the anatomic variation in the CFA and its bifurca-
tion. Ultrasound-guided access has emerged as a superior technique and has
multiple advantages over fluoroscopy. The ultrasound image will allow the opera-
tor to directly visualize the CFA and its bifurcation. In some patients, it may also
show the inguinal ligament. In addition, the needle can be directed in real time
toward the anterior wall of the CFA and can be seen going through the anterior wall
of the CFA but not the posterior wall. Disease and calcifications in the CFA can
also be seen and avoided. Ultrasound-guided access has been shown in a multi-
center randomized controlled trial to improve CFA cannulation in patients with
high CFA bifurcations. It also reduced the number of attempts to obtain access,
decreased the total time to sheath insertion, and decreased the risk of venipuncture.
In addition, ultrasound guidance significantly decreased access site complications
(1.4% vs. 3.4%, p = 0.04), a finding that was driven by reductions in access-site
hematomas [8].
Advancements in percutaneous technologies have resulted >90% technical suc-
cess rates in peripheral interventions. As such, interventionalists have begun to
tackle and treat more complex disease that would have been traditionally treated
with surgery or more conservative measures. For these reasons, situations arise in
which alternative access sites are needed to successfully perform femoropopliteal
and infrapopliteal interventions, especially chronic total occlusions. Popliteal
Fig. 7.2 Access with

micropuncture needle and
wire. After resistance was
encountered, fluoroscopy
showed the wire in a pelvic
branch (arrow) instead of
going into the iliac system
through the common iliac
artery stent (star)
artery access is attractive because it supports 57F sheaths and provides support
for retrograde crossing, and balloons/stents can be deployed. The success rate of
popliteal access is >90% and almost 100% if ultrasound guidance is used. In an
effort to decrease vascular complications, it has been recommended to screen
patients with ultrasonography and exclude those with heavy calcifications of the
popliteal artery or those with popliteal aneurysms [9]. A micropuncture needle is
also recommended especially the echogenic tip needle that may be used more eas-
ily with ultrasound. The most common access-related complications of the popli-
teal artery included popliteal artery hematomas, AV fistulae, and pseudoaneurysms
(Figs. 7.3 and 7.4).
Pedal access may be very helpful in recanalizing the popliteal and infrapopliteal
arteries, particularly in patients with critical limb ischemia as the disease is usually
lengthy, calcific, and occlusive. It is best to assess the pedal arteries with ultrasound
prior to the procedure, or if an antegrade sheath is present in the common femoral
100 M. Abu-Fadel
Fig. 7.3 Color Doppler ultrasound

of the popliteal artery showing an
AV fistula as a complication of
popliteal artery access for interven-
tion on a totally occluded superficial
femoral artery
Fig. 7.4 Angiogram demonstrating

a large pseudoaneurysm (star) in the
proximal popliteal artery 2weeks
after accessing this artery for an
intervention on a totally occluded
superficial femoral artery. This was
successfully treated with a
self-expanding covered stent
Fig. 7.5 Bleeding from

wire perforation after
diagnostic angiogram from
the radial artery causing
compartmental syndrome
requiring fasciotomy
or popliteal arteries, antegrade contrast injections with direct arterial puncture under
fluoroscopy can be done. Complications include hematoma and rarely dissection,
compartment syndrome, thrombosis, and occlusion of the vessel which may be cat-
astrophic in some cases [10].
Brachial and radial access may be used for aortoiliac, CFA, and proximal super-
ficial femoral artery interventions. The brachial artery may be more prone to com-
plications. Thus, the radial artery is more commonly used. The risk of bleeding from
the radial artery is small compared to other vascular beds. More frequent and seri-
ous complications include radial artery occlusion reported to occur in up to 4% of
patients. Patent hemostasis has been shown to reduce the risk of radial artery occlu-
sion to 1% [11]. Pseudoaneurysms are uncommon in the radial artery but may occur
and present late. The treatment is with ultrasound-guided compression, thrombin
injection, or surgery. Moreover, wires or catheters may cause perforation along the
radial artery or any of its side branches. The incidence is reported to be 0.01% [12].
If the perforated segment of the radial artery can be or is already crossed with a
wire, continuing with the procedure while the sheath or guide catheter covers the
perforation site may help seal the perforation. An angiogram of the artery at the end
of the case should be performed to confirm that the perforation has been sealed. If
the segment cannot be crossed, applying a pressure dressing or inflating a blood
pressure cuff along the course of the radial artery will often seal the leak.
Compartment syndrome is rare and has been reported to occur in 0.004% of patients
in one large case series [13] (Fig. 7.5).
7.3 Access Site-Related Complications
Even after ideal arterial access using all available techniques and equipment by the
most experienced operators, access site complications and bleeding may still occur
after sheath removal or closure device deployment. While all access-related compli-
cations are serious and important, in this chapter, we shall briefly discuss some of
the more serious complications associated with vascular access.
102 M. Abu-Fadel
7.3.1 Pseudoaneurysms
A pseudoaneurysm (PSA) occurs when an arterial puncture site does not adequately
seal and causes a contained rupture with disruption in all three layers of the arterial
wall. Pulsatile blood leaving the artery into the perivascular space causes a hema-
toma that then forms the wall of the PSA.The incidence of PSA after diagnostic
angiograms can be as high as 2%. This number may reach up to 8% following
peripheral interventions and probably relates to the presence of more common fem-
oral disease as well as risk factors that are associated with more difficult hemostasis
(e.g., ESRD, DM) [14, 15]. PSAs usually present as pain and swelling at the access
site. Large PSAs may cause local compression of the structures in the femoral
sheath leading to neuropathy, deep thrombosis, claudication, or, rarely, critical limb
ischemia. Subjectively, the patient will experience groin pain disproportionate to the
physical findings including a palpable pulsatile mass or the presence of a systolic
bruit. There may also be skin ischemia and necrosis if the PSA is large and tense.
The diagnostic test of choice is Doppler ultrasonography of the access site that has
94% sensitivity and 97% specificity to identify a PSA (Fig. 7.6).
Different therapeutic strategies have been validated to treat PSA, including sim-
ple manual compression, ultrasound-guided compression, and ultrasound-guided
thrombin injection. In general, if the PSA is <10mm, most will resolve spontane-
ously with no intervention. It is recommended to follow them with ultrasound on a
biweekly basis until resolution. A treatment algorithm based on the morphological
Fig. 7.6 Color Doppler

ultrasound showing a
pseudoaneurysm (PSA) at
the common femoral artery
access site with a narrow
neck (arrow) and
to-and-fro blood flow in
the PSA
features of PSA has been developed, evaluated, and published by Dzijan-Horn etal.,
which has resulted in an overall PSA treatment success rate of 97.2% with an
acceptable complication rate of 1.5% [16]. According to the algorithm, small PSAs
(diameter <20mm), PSAs without clearly definable neck, PSAs directly adjacent to
vessels, and PSAs with concomitant arteriovenous fistula were treated by manual
compression. On the other hand, large PSAs and those with definable neck and
away from the vessels and with no arteriovenous fistula were treated by ultrasound-
guided thrombin injection. There were few patients who crossed over between man-
ual compression and thrombin injection. When followed, the treatment algorithm
for post-procedural PSAs was not successful in 12 of 428 patients (2.8%). Ten of
these patients required surgical repair, which by itself had a 30% complication rate.
The other two patients required covered stents to exclude the PSA.It is thus recom-
mended that even in case of initial treatment failure, it is worth performing further
attempts according to this algorithm before escalating therapy toward surgical repair
[16]. In other series, surgical repair of PSA was reported to have complication rates
as high as 6070%. In the current era, surgical repair is left as a last resort of treat-
ment for PSAs and mainly done in the setting of failure of percutaneous interven-
tion, rapid expansion of PSAs, recurrence, skin necrosis, nerve palsy, limb ischemia,
and infected (mycotic) PSAs.
Ultrasound-guided compression involves the location of the PSA neck with
ultrasound and then applying pressure with the ultrasound probe directly over the
neck to completely occlude the flow into and out of the PSA.Pressure is applied
initially for 2025min, after which more pressure may be applied if the flow is still
seen with Doppler ultrasound. Applying direct pressure is usually painful for the
patient, and sedation or pain control should be given prior to staring the compres-
sion. A follow-up ultrasound is usually performed at 24h and 1 week to confirm that
the PSA remains closed. Some of the risks associated with this technique involve
distal embolization of the thrombin material into the arterial circulation. The s everity
of the complication will vary, but most of these patients will require urgent angiog-
raphy for diagnostic purposes and intervention as deemed clinically necessary.
Ultrasound-guided thrombin injection is done if compression of the neck fails to
occlude the PSA and it involved visualizing the PSA under Doppler ultrasound and
injecting under direct visualization thrombin into the PSA sac. The amount of
thrombin injected may vary from patient to patient, and it is best to inject just
enough thrombin in the base of the PSA away from the neck slowly over 1015min
until there is cessation of color flow by Doppler in the PSA.Patients are kept on bed
rest for at least 6 h, and a follow-up Doppler is done at 24 h and 1 week post-
procedure. A multiloculated PSA may require thrombin injection into its different
lobes to assure complete resolution. There are some reports of applying balloon
occlusion at low pressures of the feeding artery while injecting the PSA with throm-
bin. This is usually done when the neck of the PSA is short or >5mm in diameter
by ultrasound. This technique may decrease the risk of distal embolization of throm-
bin into the circulation and the risk of iatrogenic limb ischemia. Other reported
ways to occlude PSA include coil embolization and covered stenting of the feeding
artery (Fig. 7.7a, b).
104 M. Abu-Fadel
a b
Fig. 7.7(a) Shows a pseudoaneurysm (star) in the proximal portion of the superficial femoral
artery (SFA) that was caused due to a low femoral arteriotomy below the femoral head and the CFA
bifurcation. This was treated successfully with a self-expanding covered stent (b)
7.3.2 Retroperitoneal Hemorrhage
Retroperitoneal hemorrhage (RPH) is the most life-threatening complication seen

with femoral-based access. The incidence of retroperitoneal hemorrhage in vascular
access-related complications is between 0.15% and 0.44% [17]. The retroperitoneal
space can accommodate a very large volume of blood even before any clinical
symptoms such as hypotension and tachycardia arise. Up to three-fourths of patients
with RPH receive blood transfusions, and mortality may be as high as 10%.
Predictors of development of a retroperitoneal bleed in the setting of peripheral
interventions included low body weight, Angioseal device use, sheath placement
above the inferior epigastric artery, female sex, use of IIb/IIIa inhibitors, and larger
sheath size [4]. Most often, patient starts showing symptoms early after the proce-
dure, but sometimes RPH may present much later. Patient can experience mild to
severe lower back and flank pain most often on the same side as the access site.
They may also complain of vague abdominal pain and distension. There is usually
no obvious sign of swelling or a hematoma at the puncture site with this form of
hemorrhage. As patients continue to bleed into the retroperitoneal space, tachycar-
dia and hypotension will develop followed by shock. A decrease in hemoglobin and
hematocrit may become evident soon after. It is important to remember that
hemodynamic compromise is usually a late sign of retroperitoneal hemorrhage, and

if it is suspected, early aggressive resuscitation measures are important. While the
gold standard for diagnosing retroperitoneal hemorrhage is computed tomography
(CT) of the abdomen and pelvis, this should be done only if the patient is stable
enough to be transferred to the radiology suite. Clinical diagnosis and rapid man-
agement remain the most important and lifesaving intervention. Two large IV lines
should be established, and blood should be prepared and kept on standby. IV fluids
should be given rapidly until blood is available. Manual pressure should be applied
to the access site even in the absence of a hematoma since sometimes the arteriot-
omy is in a compressible location. Anticoagulation medication should be held if
possible, and surgical evaluation should be sought depending on the severity of
retroperitoneal hemorrhage and, if it is ongoing, causing hemodynamic compro-
mise [18]. Intervention should be performed on patients with refractory hypoten-
sion or on patients with an active blush on computed tomography. Either surgical
repair or endovascular balloon tamponade or exclusion with a covered stent can be
performed [19]. If during femoral angiography the sheath is noted to be high, off-
label use of suture-mediated closure devices for arteriotomies above the most infe-
rior defection of the inferior epigastric artery and contralateral access with balloon
tamponade (and covered stenting if needed) have been reported and utilized as a
preventive measure to avoid RPH in high-risk patients.
7.3.3 Arteriovenous Fistula Formation
Throughout the body, arteries and veins are closely associated and paired with each
other. As such any faulty instrumentation of one of the structures may lead a com-
munication between the artery and vein causing and acquired arteriovenous fistula
(AVF). In case of endovascular procedures, AVF is a communication between the
artery and vein at the access site that cause a continuous flow of arterial blood into
the venous system (Figs. 7.3 and 7.8). This is most commonly caused by lateral or
medial needle deviation or needle placement during access leading to combined
arterial and venous puncture. If the sheath is placed, the communication will get
larger and may lead to AVF in the right setting. Another important factor is access-
ing both the common femoral artery and vein at the same level and not holding
adequate pressure for hemostasis. This may cause a communication between the
two structures the lead to an AVF.Although less common, iatrogenic AVF can result
from devices used in peripheral and venous interventions such as endovenous laser
for saphenous ablation, percutaneous directional atherectomy, and devices used for
reentry during subintimal angioplasty.
In most cases, the communication is small and seals off spontaneously. However,
in some patients with increased risk such as older patients, females, patients with
high body mass index, patients with hypertension, those receiving anticoagulation
or antifibrinolytic therapy, or those undergoing left-sided access, low or multiple
needle punctures are at higher risk of acquiring an AVF [20, 21]. While this is
106 M. Abu-Fadel
Fig. 7.8 Distal aortography

with bilateral iliofemoral
angiography showing a left
arteriovenous fistulae (AVF)
at the level of the superficial
femoral artery in a patient
not known to have periph-
eral arterial disease previ-
ously and not known to have
the AVF
u sually painless, a thrill and/or a bruit could be felt/heard on physical exam of the
groin. Long-standing AVFs can lead to limb edema or ischemia due to steal, high-
output cardiac failure, or aneurysmal degeneration of the artery [22]. Duplex ultra-
sound is the diagnostic test of choice for evaluating patients with suspected AVFs.
Angiography may be needed in some cases. Some of the AVFs are also diagnosed
incidentally when a patient presents for repeat angiography.
Treatment options depend on the size and the symptoms associated with the
AVF.In general, most small, asymptomatic AVFs will thrombose spontaneously. In
those causing symptoms, surgery remains the gold standard, but other modalities
are being used more frequently including ultrasound-guided compression and endo-
vascular interventions if feasible. Unlike with PSAs, ultrasound-guided compres-
sion of AVFs is not as effective in obliterating the AVF especially if it has been
present for over 2weeks or the patient is on anticoagulation [23]. In general the
procedure is successful in up to about 30% of patients. Compression is done for at
least 10min under direct visualization and without compromising distal flow into
the extremity. This is usually a painful procedure; therefore, the use of sedation or
pain medication is recommended. For those patient who develop symptoms due to
AVF, including edema of the lower extremity, ischemia, high-output heart failure, or
progressive enlargement of the AVF with increase in shunting or recurrence after

conservative management, it is recommended that they undergo repair either surgi-
cal or endovascular. Covered stent placement or embolization techniques may be
effective as an alternative to surgical repair for high-risk patients. However, the use
of stents depends upon the location of the fistula. In general covered stents are best
avoided in the common femoral artery but may be a good choice in the superficial
femoral artery.
7.3.4 Other Access Site-Related Complications
Other access site-related complications include hematomas, dissections, arterial

occlusions, infections, and others. Table 7.1 presents a brief discussion about these
complications. The utilization of the radial artery for some peripheral interventions
has allowed early ambulation and fewer access site-bleeding complications. In addi-
tion, while this access site is not suitable for all patients, it may provide an easier
intervention in some anatomical situations [24]. Equipment size and shaft length
may prohibit the use of the radial artery in many peripheral interventions especially
in the distal lower extremity vascular beds.
Vascular closure devices seem to be at least non-inferior to manual compression
and in real-life registry data even superior in decreasing vascular access site compli-
cations. However, these devices seem to have a set of complications that are specific
to them, and care should be taken on whom they should be used. Screening with
femoral angiography while or directly after obtaining femoral artery access and
avoiding the use of anticoagulation in patients with high or low arteriotomies as
well as the avoidance of vascular closure devices in the presence of puncture site-
related risk factors might reduce the risk of vascular complications.
7.4 Anticoagulation Use-Related Complications
The use of bivalirudin vs. unfractionated heparin (UFH) in patients undergoing

endovascular peripheral interventions (EPI) has been reported in several studies.
Some of these studies have suggested that bivalirudin offers the same efficacy as
UFH but with reduced bleeding complication rates [25]. However, a meta-anal-
ysis that included a total of 1249 patients enrolled in four nonrandomized clini-
cal trials comparing UFH to bivalirudin showed that there was no significant
difference between the two arms in terms of total bleeding complications (RR
0.64, 95% CI 0.311.34). Similarly, no difference was observed in terms of
major bleed (RR 0.58, 95% CI 0.21.65) or minor bleed (RR 0.66, 95% CI
0.381.61) [26].
108 M. Abu-Fadel
Table 7.1 Modified from Critical Care Nurse Vol 32, No. 5, OCTOBER 2012
Complication Description Clinical findings Management
Hematoma The most common Visible swelling Apply pressure to site.
Incidence: vascular access site surrounding the Mark the area to evaluate for
523% complication. puncture site. any change in size.
A collection of blood Area of hardening If large, monitor serial blood
located in the soft under the skin cell counts and give IV
tissue. surrounding the fluids.
May occur if the puncture site that Maintain/prolong bed rest.
arterial puncture is will vary in size. Interrupt anticoagulant and
below the inferior Often associated antiplatelet medications if
boarder of the with pain in the needed, and transfuse blood
femoral head or groin area that can if indicated.
below the CFA occur at rest or If severe, may require
bifurcation with leg surgical evacuation.
movement. Many hematomas resolve
Can result in within a few weeks as the
decrease in blood dissipates and is
hemoglobin and absorbed into the tissue
blood pressure and
increase in heart
rate, depending on
severity
Retroperitoneal Bleeding that occurs Moderate to severe Two large bore intravenous
hemorrhage behind the serous and sometimes lines for intravenous fluid
Incidence: membrane lining the vague abdominal resuscitation.
0.150.44% walls of the abdomen or back pain. Perform serial blood cell
and pelvis. Ipsilateral flank counts.
May occur if the pain. Maintain/prolong bed rest.
arterial wall puncture Ecchymosis and Interrupt anticoagulant and
is made above the decrease in antiplatelet medications.
inguinal ligament, hemoglobin and Blood transfusion, if
resulting in hematocrit are late indicated.
perforation of the signs. If severe, may require
external iliac artery Abdominal surgical evacuation or
or penetration of the distention. endovascular treatment in
posterior wall. Often not the catheterization lab
Can be fatal if not associated with
recognized early obvious swelling
or hematoma.
Hypotension and
tachycardia.
Diagnosed
clinically and
confirmed by
computed
tomography or
angiography
(continued)
Pseudoaneurysm A communicating Swelling at Maintain/prolong bed rest.
Incidence: tract between the insertion site. Small femoral
0.59% tissue and, usually, Large, painful pseudoaneurysms should be
one of the weaker hematoma. monitored; they commonly
walls of the femoral Ecchymosis. close spontaneously after
artery, causing blood Pulsatile mass. cessation of anticoagulant
to escape from the Bruit and/or thrill therapy.
artery into the in the groin. Large femoral
surrounding tissue. Pseudoaneurysms pseudoaneurysms can be
Possible causes can rupture, treated by ultrasound-guided
include difficulty causing abrupt compression, surgical
with arterial swelling and severe intervention, or ultrasound-
cannulation, pain. guided thrombin injection
inadequate Suspect nerve
compression after compression when
sheath removal, and pain is out of
impaired hemostasis. proportion to size
May occur if the of hematoma.
arterial puncture is Nerve compression
below the inferior can result in limb
boarder of the weakness that takes
femoral head or weeks or months to
below the CFA resolve.
bifurcation Diagnosed by
ultrasound
Arteriovenous A direct Can be Some arteriovenous fistulae
fistula communication asymptomatic. resolve spontaneously
Incidence: between an artery Bruit and/or thrill without intervention.
0.22.1% and a vein that occurs at access site. Some arteriovenous fistulae
when the artery and Swollen, tender require ultrasound-guided
vein are punctured. extremity. compression or surgical
The communication Distal arterial repair
occurs once the insufficiency and/
sheath is removed. or deep venous
Risk factors: thrombosis can
Multiple access result in limb
attempts ischemia.
Punctures above or Congestive heart
below ideal CFA site failure.
Impaired clotting Confirmed by
mechanisms ultrasound
(continued)
110 M. Abu-Fadel
Arterial occlusion Occlusion of an Classic symptoms Treatment depends on size/
Incidence: artery by a include the 5 Ps: type of embolus, location,
<0.820% thromboembolism. Pain and patients ability to
Most common Paralysis tolerate ischemia in affected
sources: mural Paresthesias area.
thrombus originating Pulselessness Small thromboemboli in
in cardiac chambers, Pallor well-perfused arterial areas
vascular aneurysms, Doppler studies may undergo spontaneous
or vascular help localize the lysis.
atherosclerotic area. Larger thromboemboli may
plaques. Angiogram is require
Thromboemboli can required to identify thromboembolectomy,
develop at sheath site exact location of surgery, and/or thrombolytic
or catheter tip; occlusion site agents.
embolization occurs Distal embolic protection
during sheath devices (i.e., filters) may be
removal. placed if necessary
Prevention or at least
reduction can be
obtained by
anticoagulation,
vasodilators, and
nursing vigilance
Femoral Nerve damage Pain and/or Identification and treatment
neuropathy caused by injury of tingling at femoral of the source.
Incidence: the femoral nerve(s) access site. Treatment of symptoms.
0.2123% during access and/or Numbness at Physical therapy
compression of access site or
nerves by a further down the
hematoma leg.
Leg weakness.
Difficulty moving
the affected leg.
Decreased patellar
tendon reflex
Infection Colonization by a Pain, erythema, Symptomatic treatment for
Incidence: pathogen swelling at access pain.
<0.120% Causes: site with possible Antibiotics.
compromised purulent discharge. Surgical removal of foreign
technique, poor Fever body such as closure device
hygiene, prolonged Increased white if necessary
indwelling sheath blood cell count
time.
Femoral access
closure device
7.5 Procedural-Related Complications
Peripheral complications include but are not limited to arterial dissections, vessel
occlusions, perforations, and distal embolization. The incidence of these complica-
tions, while low in general, is higher in patients undergoing recanalization of chronic
total occlusions than for stenotic vessels. Analysis of a large national database of
patients undergoing peripheral interventions shows the overall complication rate to
be 14.46%. These complications were noted to be significantly lower (13.36%) in
high-volume centers (fourth quartile with >126 peripheral interventions/year) as
compared to the lowest-quartile-volume centers (36 cases/year) with a complica-
tion rate of 15.66% (p < 0.001). Similarly, the in-hospital mortality, amputation rate,
and vascular complications were all significantly lower in the highest-volume cen-
ters compared to the lowest-volume ones [27]. In addition, a multivariate analysis
revealed age, female gender, and baseline comorbidities to be significant predictors
of mortality. Emergent/urgent procedures as well as weekend admissions also pre-
dicted higher complication rates and worst outcomes [27].
Perhaps the most appropriate method to manage complications is to avoid them.
Since this is not always possible, it is of utmost importance for any interventionalist
to be familiar with diagnosing and treating complications associated with peripheral
interventions. Preprocedural planning and knowing each patients anatomy are cru-
cial to determine if and what endovascular strategy is possible and to help decrease
complication rates. For CTO interventions, the proximal and distal level of the
occlusion and the pattern of the collateral circulation should be assessed to help in
choosing what strategy and approach to take during the intervention. These strate-
gies may include access site, retrograde vs. antegrade approach to cross the occlu-
sion, and how to best avoid severing collateral flow, which may lead to worsening
ischemia if revascularization is not achieved during the same setting.
7.5.1 Perforations
Perforations can occur from a variety of causes. Most commonly they are due to
wire perforations; however, balloon angioplasty-, stenting-, or atherectomy-related
perforations are also common. If unrecognized or not managed appropriately, they
may result in significant morbidity and even mortality [28]. The most important
factors of patient outcomes are the location of the perforation and the speed of
recognition [29]. Bleeding in the pelvis, abdominal cavity, or thorax is life-threat-
ening, while bleeding in a compartmentalized space such as the arm or leg is usu-
ally less severe but may still lead to major morbidity such as compartmental
syndrome.
Perforations may be more easily avoided in non-CTO interventions since good
angiographic imaging and the use of road maps can help keep wires and devices
in the true lumen. In addition, vessel architecture, size, plaque burden, and plaque
112 M. Abu-Fadel
orientation can be more easily assessed. In CTO interventions, vessel wall

calcifications can help guide the operator advance wires in the direction of the
vessel architecture and may provide a road map of the vessel lumen. While it
would be easy to recognize when the wire traverses outside the calcified vessel
wall, if the artery is not calcified, especially in iliac CTO interventions, the opera-
tor will need to assess the wire position carefully before proceeding with the inter-
vention [28].
Wire perforations are the most common and usually occur in the distal vascular
beds or in small side branches (Fig. 7.9). In general, straight, stiffer, and hydrophilic
wires tend to cause more perforations. While some wire perforations may be serious
in the coronary of cerebral circulation, in general, wire perforations in the lower
extremities are minor and most of the time will seal on their own. Very rarely the
operator will need to abandon the procedure or reverse anticoagulation. Most impor-
tant is to recognize when a guidewire has perforated the vessel to prevent worsening
the complication by advancing a larger catheter or performing angioplasty across
the perforation. If the perforation does not stop spontaneously, inflating a manual
blood pressure cuff around the extremity to above systolic pressures for 35min
around the area of perforation can stop the bleeding. This usually works for both
main vessel and side branch perforations especially in the SFA circulation. In other
cases, balloon tamponade with a low-pressure inflation (24atm) to occlude flow
across the perforation or the perforated side branch will be sufficient. Coiling may
be the best option especially if the wire perforation is in a small side branch and not
responding to conservative measures. Balloon tamponade alone or placement of a
covered stent in the SFA to exclude the origin of the side branch may not entirely
stop the bleeding because collateral pathways may continue to perfuse the injured
vessel [28].
Balloons, stents, and atherectomy devices usually cause larger perforations or
vessel tears and ruptures. While these complications are less frequent, they are, in
general, more severe (Fig. 7.10ad). As a rule, larger diameter vessels are more at
risk of perforation with stretching than those with smaller vessel diameters. This is
important to keep in mind when performing interventions on iliac arteries and distal
aorta. When stretched, larger arteries will cause the patient to feel pain, and this
should be a sign to refrain from further balloon dilatation or stent expansion. Factors
known to increase the risk of perforations during lower extremity interventions
include diabetes, older age, and critical limb ischemia [30]. Other factors that may
contribute to vessel rupture include CTOs, oversizing of balloons and balloon-
expandable stents, high inflation pressures especially in calcified, and difficult to
dilate lesions. Even nominal pressure inflations in calcified and totally occluded
vessels may lead to perforations. Atherectomy-related perforations happen due to
direct shaving or mechanical disruption of the adventitial layer of the vessel wall.
Depending on the atherectomy device used, the procedural perforation rate will
vary between 0.5% and 5.3% [3134].
Similar to wire perforations, the outcomes of device-related perforations depend
on the severity and location of the complications. Dye extravasation, especially in a
Fig. 7.9 Wire perforation during an intervention on a totally occluded superficial femoral artery.
A hydrophilic wire went into a small branch of the collateral and caused the perforation (arrow).
The procedure was completed successfully, and anticoagulation was not reversed. The perforation
sealed after crossing the SFA and ballooning across the takeoff of the collateral for a minute
114 M. Abu-Fadel
a b c d
Fig. 7.10(a) Shows a large perforation caused by a chronic total occlusion (CTO) crossing device
while attempting to cross a CTO of the popliteal artery. A blood pressure cuff was inflated around
the site of perforation for 3min. While the cuff was inflated, there was no flow to the distal extrem-
ity, and the perforation was not bleeding (b). After the blood pressure cuff was deflated, repeat
angiogram showed resolution of bleeding (c). The procedure was completed successfully using a
wire and catheter to cross the occlusion successfully and revascularize the popliteal occlusion (d)
body cavity such as the pelvis from iliac perforations (Fig 7.11a, b), represents the
most severe finding that may lead to hemorrhagic shock and death and should be
dealt with promptly. An extravascular blush or stain that persists on fluoroscopy
represents a contained perforation that is usually smaller in size. Due to the life-
threatening nature of iliac perforations, a 7F sheath is usually recommended for
iliac interventions especially CTOs to allow the advancement and deployment of
covered stents if needed urgently. The first step in treating device-related perfora-
tion is to make sure there is adequate wire across the lesion and to promptly perform
a low-pressure balloon inflation across the ruptured vessel. The balloon size should
be 1 to 1 with the vessel lumen at the site of rupture and typically long enough to
straddle the perforated segment. The balloon is kept inflated for 35 min at 24
atmospheres. If possible, angiography may be performed to confirm that the balloon
is completely sealing the perforation. If the complication did not resolve, repeat
balloon inflation may be performed especially if the perforation is getting resolved.
Many operators will elect to reverse the anticoagulation however; this may not be
possible with some anticoagulants such as bivalirudin or in some cases that require
prolonged balloon inflation which may cause distal vessel thrombosis thus convert-
ing one bad complication into two. If balloon tamponade is not sufficient to seal a
perforation, then a covered stent may be needed. Similar to other types of stents,
there are two types of covered stents self-expanding (such as the Viabahn or
WallFlex covered stent) and balloon expandable (such as the iCAST or
LIFESTREAM covered stent). In general, self-expanding covered stents are used in
the infrainguinal and external iliac vessels, and balloon-expandable stents are used
a b
Fig. 7.11 Rupture of the iliac artery after postdilating the stent that was implanted to revascularize
a totally occluded common iliac and external iliac artery. The contrast was free flowing into the
retroperitoneal space (arrow) (a), and the patient developed hypotension within seconds. A balloon
was used to tamponade the perforation, and a balloon-expandable covered stent was used to suc-
cessfully seal the perforation (b)
in the common iliacs and distal aorta. The coronary balloon-expandable

GRAFTMASTER or JOMED JOSTENT may be used in the infrapopliteal vessels.
When using covered stents, it is important to decide on the appropriate stent diam-
eter and length to avoid overstretching the vessel further and avoid occluding
important side branches such as the internal iliac artery. At the same time, it is criti-
cal to completely cover the perforation to seal it off completely. In some cases, the
patient may require surgical intervention to obtain hemostasis, but this is rare in the
current era.
7.5.2 Dissections
Arterial dissections during peripheral interventions can be divided into three main
categories. The first is the access site-related dissections. These, in general, are
retrograde dissections that may be tacked up by the antegrade blood flow in that
vessel (Fig. 7.12). If there is no pressure gradient across the dissection and it is
small in size, one may elect to be conservative and follow up the dissection by
noninvasive testing. One important aspect during the evaluation of such dissec-
tions is the fact that the pressure gradient as well as the angiographic appearance
may be mild if there is a wire across the vessel that is holding the dissection flap.
It may be important to evaluate the dissection after the wire is removed to make
sure it does not transform into a hemodynamically significant dissection. In cases
116 M. Abu-Fadel
Fig. 7.12 External iliac

artery retrograde dissection
(arrow), which is caused
either due to the tip of the
sheath that is against the
wall of the artery (star) or
due to the wire going
subintimal after exiting the
sheath
where the dissection is compromising blood flow to the distal extremity, stenting
with a self-expanding stent may be necessary. If the dissection is severe and
involves the CFA, surgery is the treatment of choice in order to prevent stenting
across that vessel.
The second type of dissection occurs at the site of angioplasty of the vessel
being treated. This is very common and in general does not require additional
treatment unless the dissection is flow limiting. In such cases, additional treat-
ment with stent placement is sufficient. Other treatment modalities such as sur-
gery or prolonged balloon inflations may be needed for dissections in CFAs
and popliteal artery if stenting is not desired or not an option. The third types
of dissections are antegrade dissections, which may propagate due to blood
flow across them. These will necessitate treatment in the majority of cases.
Treatment is mainly with stenting, and this can be easily achieved if a wire is
already across the lesion. However, if there is no wire across the lesion or the
wire is lost during the intervention, it may be difficult to rewire across the dis-
sected segment especially if there is a spiral dissection or the flow is com-
pletely occluded. In such cases, alternative access may be required to approach
the dissection from a retrograde fashion or subintimal dissection, and reentry
techniques may be used to reenter the true lumen and stent across the dissected
segment. Surgery to fix such a complication is rarely needed with the current
equipment and techniques that are being used.
7.5.3 Distal Embolization
Distal embolization (DE) of plaque or thrombus material during peripheral inter-

ventions may cause limb ischemia and sometimes worsen the clinical presentation
especially in patients with critical limb ischemia. DE may occur during guidewire
crossing, atherectomy, balloon angioplasty, and stent deployment (Fig. 7.13). In a
retrospective analysis of 2137 lesions treated in 1029 patients with multiple modali-
ties, the embolization rate was 1.6% [35]. In the same analysis, the embolization
rate was significantly higher in TASC II C and D compared to TASC A and B lesions
as well as for in-stent restenosis and CTO lesions compared to stenotic lesions. In
addition, the Jetstream Pathway and Diamondback 360 devices had a significantly
higher distal embolization rate (22%) as compared to balloon angioplasty alone
(0.9%), balloon and stent (0.7%), SilverHawk (1.9%), and laser atherectomy (3.6%)
[35]. It is important to mention that patency was restored in 94% of the patients that
had distal embolization during the same procedure. There was no difference in the
clinical outcome between patients with DE and those without.
In general, a distal runoff angiography should be performed after percutaneous
revascularization of any vascular bed to evaluate for evidence of DE.Angiographic
predictors of DE include CTO; long, irregular, and calcified lesions; as well as
thrombotic occlusions. Distal embolization is mainly divided into two different
types, micro- and macro-embolization. The clinical manifestation of either kind
depends on the burden of material embolized and the vascular bed affected by the
embolization. While such embolization may be catastrophic in the coronary or cere-
bral circulation, most of the time, it is of no clinical significance in the lower
extremities. A major difference between micro- and macro-embolization is that in
patient with micro-embolization, the capillary beds will get obstructed and collat-
eral flow will not help the overall outcome and clinical picture. On the other hand,
collateral flow may preserve a limb in cases with macro-embolization.
Prevention of DE may be the best treatment strategy. Although there are no pro-
spective randomized data to support its use, and there are no devices approved for
infrainguinal use, embolic protection devices (EPDs) are being used by many oper-
ators for that purpose especially with thrombectomy devices. Data from a number
of small heterogeneous series of patients where EPDs were used during lower
extremity interventions suggest that DE is very common in such interventions espe-
cially with atherectomy device usage and that the majority of DE occur during the
procedure for acute and subacute lesions [36]. Filter clotting may result in cessation
of distal flow, limiting angiographic assessment of the runoff vessels. Furthermore,
EPD does not protect proximal collateral vessels, and the device itself may cause
arterial spasm, injury, or de novo thrombus formation [37, 38].
A number of treatment strategies are possible in case of DE. Strategies differ
depending on the type of DE and the duration since onset. Aspiration embolectomy,
thrombolysis (if no contraindications), balloon angioplasty and stenting, open
118 M. Abu-Fadel
a b
Fig. 7.13 After revascularization of the distal aorta, a runoff was performed, and distal emboliza-
tion to the tibioperoneal trunk was noted (white arrow) with decrease perfusion of the distal arter-
ies (a). Multiple attempts were made to aspirate the atheroma but were not successful so a stent
was placed successfully across the embolized material (black arrow) (b)
s urgical thrombectomy, or any combinations are all possible treatment options. The
choice between endovascular treatments vs. open surgical options depends on the
etiology and location of the occlusion as well as general contraindications to surgi-
cal revascularization and/or the use of lytic agents.
7.5.4 Blue Toe Syndrome
Blue toe syndrome (Fig. 7.14) is caused by occlusion of small- and medium-caliber
arteries (100200 m in diameter) by cholesterol and may be a complication of
peripheral intervention. Cholesterol embolism is a challenge to diagnose and treat
effectively. Livedo reticularis in the presence of good peripheral pulses is the most
common skin manifestation of cholesterol embolism and is seen in 5075% of skin
lesions [39]. Other skin findings include necrosis and acrocyanosis or blue toe syn-
drome. The diagnosis is usually made clinically, and the provider should have a high
index of suspicion especially in patients who had a recent instrumentation of the
systemic circulation. This happens due to events or procedures that disrupt unstable
atherosclerotic plaques, most frequently during invasive vascular procedures, and
the administration of anticoagulants or thrombolytics. The most common sites for
severe atherosclerotic disease are the abdominal aorta and the iliac and femoral
arteries thus making interventions on the lower extremities an important iatrogenic
cause blue toe syndrome.
Cholesterol crystals are showered into the bloodstream and migrate distally until
they lodge in small arterioles. This causes an acute inflammatory response which in
Fig. 7.14 Blue toe

syndrome seen in a patient
after iliac artery
intervention
120 M. Abu-Fadel
turn triggers a cascade of events leading to intravascular thrombus formation, endo-

thelial proliferation, and, eventually, vessel fibrosis. Clinical manifestations may be
immediate or a delay of several months. A study by Belenfant etal. of patients with
cholesterol emboli found that the precipitating event occurred an average of
2months prior to recognition of fulminant disease [40]. Cholesterol emboli may
also cause a variety of other clinical manifestations including systemic, renal, gas-
trointestinal, and others which are beyond the scope of discussion of this book chap-
ter. Patients with cholesterol emboli develop eosinophilia within few days, and the
levels may remain elevated for up to a month. Treatment options are limited, and
data is conflicting about some therapeutic approaches such as anticoagulation. In
general, withholding all anticoagulation and thrombolysis if possible is helpful even
though there are some reports of treating cholesterol emboli with anticoagulation.
Do not attempt further endovascular procedures to decrease the risk of further cho-
lesterol embolization. Long-term high-dose statins is important and modifying
other risk factors.
7.6 Conclusion
Endovascular procedures have come a long way in terms of safety, efficacy, and
procedural success rate. Like with any other invasive procedure, complications will
occur, and some may cause significant morbidity and even mortality. While rela-
tively rare, early diagnosis and treatment of complications during interventions of
the lower extremity arterial beds remains critical to save limbs and lives. Perhaps
the best treatment strategy is prevention by paying careful attention to procedural
details as well as pre- and post-procedural care and planning.
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Practical Approach To PACTO

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Practical Approach to

ISBN 978-981-10-3052-9ISBN 978-981-10-3053-6(eBook)

Library of Congress Control Number: 2017936690

Springer Science+Business Media Singapore 2017

Printed on acid-free paper

This Springer imprint is published by Springer Nature

Dallas, TX, USA SubhashBanerjee

1 Medical Management ofLower Extremity Peripheral

1.2 Risk Factor Modification

1.2.1 Tobacco Use

A.Y. Patel, MD H.S. Gurm, MD (*)

Springer Science+Business Media Singapore 2017 1

1.2.2 Hyperlipidemia, Hypertension, andDiabetes

1.3.1 Smoking Cessation Therapy

1.3.2 Lipid Lower Therapy withStatins

Though the control of hypertension by any antihypertensive is beneficial in reduc-

1.3.4 Antiplatelet Therapy

1.4 Therapeutics: Improvement ofFunctional Capacity

1.4.1 Supervised Exercise Therapy (SET)

ginkgo biloba extract x

Fig. 1.1 Peripheral arterial disease therapeutics

Cilostazol is a unique drug in that it inhibits phosphodiesterase 3 leading to an

Various therapeutics have been trialed in the treatment of PAD to no avail.

Peripheral arterial disease is a common and often underdiagnosed and undertreated

1. Pasternak RC etal. Atherosclerotic vascular disease conference: writing group I: epidemiol-

K. Bishu, MD, MS E.J. Armstrong, MD, MSc, MAS (*)

Springer Science+Business Media Singapore 2017 9

may instead be related to underlying characteristics of the occluded segment (e.g.,

2.2 Outcomes After Endovascular Treatment ofIliac CTOs

Endovascular recanalization assisted with stenting is increasingly being performed in

types. Papakostas et al. treated iliac CTOs in 56 limbs in 48 patients by the

2.3 Treatment Strategies andIllustrative Cases

The approach to iliac CTO endovascular recanalization primarily depends on the

2.3.1 Overall Approach andTreatment Strategy

Endovascular treatment of iliac artery CTOs should be based on detailed pre-

2.3.2 Ostial Common Iliac or Aortic Bifurcation

Such an approach will usually prohibit contralateral crossover during subsequent

2.3.4 Distal External Iliac Artery CTOs

tomography angiography (CTA), magnetic resonance angiography (MRA), and invasive

Common iliac arteries

External iliac arteries Internal iliac arteries

Fig. 3.1 Abdominal aortogram

CTO body CTO Lesion

b Wire - catheter Crossing of SFA CTO

Primary technical success

Provisional technical success

Patient factors in FP CTO procedure planning include: symptom status, body

1. Define lesion XLPAD CTO Classification

2. Define approach Antegrade, retrograde, hybrid

3. Define device Wire-catheter, CTO crossing device

Fig. 3.6 XLPAD approach to femoropopliteal CTO: four key steps

Ambiguous proximal cap

Tapered proximal cap +

Tapered proximal cap Type IA Type IB Type IC

Length <50 mm Length 50-100 mm Length >100 mm

Antegrade Antegrade or retrograde approach Retrograde

Ambiguous proximal cap

Tapered proximal cap + Type IIA Type IIB Type IIC

Type IA Type IB Type IC

Length <50 mm Length 50-100 mm Length >100 mm

Antegrade Antegrade or retrograde approach Retrograde *Heavy calcification

Table 3.1 Guidewire options for femoropopliteal CTO intervention

Boston Scientific Cook Cordis Abbott Terumo Asahi

Dallas, TX, USA SubhashBanerjee

1 Medical Management ofLower Extremity Peripheral

1.2 Risk Factor Modification

1.2.1 Tobacco Use

1.2.2 Hyperlipidemia, Hypertension, andDiabetes

1.3.1 Smoking Cessation Therapy

1.3.2 Lipid Lower Therapy withStatins

1.3.4 Antiplatelet Therapy

1.4 Therapeutics: Improvement ofFunctional Capacity

1.4.1 Supervised Exercise Therapy (SET)

2.2 Outcomes After Endovascular Treatment ofIliac CTOs

2.3 Treatment Strategies andIllustrative Cases

2.3.1 Overall Approach andTreatment Strategy

2.3.2 Ostial Common Iliac or Aortic Bifurcation

2.3.4 Distal External Iliac Artery CTOs

3.1 Retrograde FP CTO Intervention

3.2.1 Peripheral Arterial Segments

3.2.2 Transcollateral Approach toFemoropopliteal CTO

3.2.3 SAFARI Technique

3.2.4 Hybrid Approach toFemoropopliteal CTO Intervention

5.2 BTK CTOs: Indications andTreatment Options

5.4 BTK CTOs: Endovascular Approach

5.4.1.1 Access: Contralateral

5.4.1.2 Access: Antegrade

5.4.1.3 Access: Retrograde Pedal Access

5.4.1.5 Access: Metatarsal andDirect Pedal Loop

5.4.1.6 Access: Radial

5.5 Crossing Approach

5.5.2 Opposite Direction Wire Strategies

5.5.3 Wire Capture

5.5.4 Extravascular Ultrasound-Guided Crossing (EVUS)

5.6 Treatment Strategies

5.6.1 Balloon Angioplasty

5.6.2 Bare Metal Stents

5.6.3 Drug-Eluting Technologies

5.7 Complications ofBTK CTO Revascularization

5.7.1 Distal Embolization

6.3 Crossing Devices (Table 6.1)

6.3.1 TruePath (Boston Scientific)